This document describes the achievements of the Association of South-East Asian Nations (ASEAN) Technical Cooperation Project in pharmaceuticals. Current ASEAN members are Brunei Darussalam, Indonesia, Malaysia, Philippines, Singapore, Thailand and Viet Nam. The Project has demonstrated that the Technical Cooperation approach is effective in promoting mutual development, with each member of ASEAN contributing expertise in some areas and acquiring skills in others. The Project now needs further support if it is to continue to build towards self-sufficiency and begin to strengthen new areas of the pharmaceutical sector where development is urgently needed. As ASEAN expands to include Cambodia, the Lao People's Democratic Republic and Myanmar, external funding sources are essential to ensure that these new members can meet the same standards of safety and effectiveness in pharmaceuticals.

The primary objective of the Project is to strengthen the pharmaceutical sectors in all ASEAN countries to ensure the sufficient and regular supplies of effective and safe essential drugs of acceptable quality. The Project was initiated in 1979 and began implementing activities in selected areas in 1982. Through cooperation among ASEAN countries, and with support from WHO, UNDP and JPMA, the pharmaceutical sectors in all ASEAN countries have benefited from the Project in many ways. Human resources have been strengthened and regional training centres established to promote self-sufficiency in training within ASEAN, guidelines and manuals on many aspects of pharmaceutical manufacture, quality assurance, herbal medicines and pharmacy management have been published, 92 ASEAN reference substances have been established to aid quality assurance and drug evaluation and control, formats for exchange of information on drug lists and essential drugs within ASEAN have been produced, and the rational use of drugs has been promoted through patient information leaflets, posters and video tapes.

This document describes the achievements of the Association of South-East Asian Nations (ASEAN) Technical Cooperation Project in pharmaceuticals. The primary objective of this project is to strengthen the pharmaceutical sectors in all ASEAN countries (Brunei Darussalam, Indonesia, Malaysia, Philippines, Singapore, Thailand and Viet Nam)^* to ensure the sufficient and regular supplies of effective and safe essential drugs of acceptable quality.

Why cooperation in pharmaceuticals?

The supply of essential drugs that are of acceptable quality, affordable, safe and effective is a crucial element in national drug policies and health programmes. Without a well-established, quality controlled manufacturing programme for pharmaceuticals, drugs have to be imported at high cost, making medicines less readily available to those that need them. Self-sufficiency in pharmaceutical manufacture, control and distribution within ASEAN was seen to have many benefits, making more money available for other aspects of the health programme, creating jobs and even an export market in the pharmaceuticals sector, and, of course, improving the overall health situation. Problems among ASEAN countries when the Project was initiated included illegally manufactured drugs, poor quality control, lack of reference substances to enable accurate analyses to be made, insufficient or unenforced legislation and too few trained personnel.

The WHO Action Programme on Essential Drugs (DAP) was established in 1981 to help countries overcome problems related to drugs and their use. Its mission is:

To contribute to reduced morbidity and mortality from common illnesses by collaborating with countries to develop and implement national drug policies and programmes which ensure equity of access to essential drugs, rational use of drugs, and drug quality. An integral part of this mission is collaboration in projects such as that established by ASEAN.

The general development objectives of the ASEAN TCAC Pharmaceuticals Project are to:

• strengthen the pharmaceutical sector so as to meet the objectives of WHO/DAP; and
  

• to achieve self-reliance in the training of human resources within the region in certain fields.

The objectives of DAP are included in Annex 2.

Since it began activities in 1982, the Project has contributed significantly to the pharmaceuticals sector in all ASEAN countries through acquiring and updating knowledge, sharing expertise and information, and developing ASEAN standards for both modern pharmaceuticals and traditional medicines.

The early phases of the Project concentrated on acquiring, updating and sharing knowledge, beginning with overseas training programmes for ASEAN nationals to increase their expertise in various aspects of pharmaceutical manufacture, quality control, drug supply management and pharmacy practice. Regional training centres were then set up in ASEAN countries to establish self-sufficiency in training of human resources and thus use available resources more efficiently.

The project also initiated exchange of information among ASEAN countries, particularly on essential drugs lists and drug regulatory matters and the development of ASEAN regional standards and reference substances for pharmaceuticals. The latter has led to greater capabilities for quality control and drug evaluation as reference substances have become more readily available. The development of standards and guidelines for herbal medicines was also an important element of the project, given the widespread use of traditional medicines in ASEAN countries.

Why technical cooperation?

Technical Cooperation Among Developing Countries (TCDC) was adopted by the United Nations in 1972, following the recommendations of a working group established to determine the best way for developing countries to share their expertise and capabilities. Technical Cooperation Among Developing Countries is defined by the United Nations Development Programme (UNDP) as the execution of developmental activities and projects by institutions in developing countries wherein they share their capabilities and experiences with a view to increasing and improving development assistance and utilize whenever necessary advice and financial support from external sources including organizations of the UN system.

The Thirty-second World Health Assembly (WHA) in May 1979 endorsed TCDC as an important mechanism for solving common problems in the area of health. Ministers of Health from ASEAN countries attending the Thirty-second WHA (Indonesia, Malaysia, Philippines, Singapore, and Thailand) supported the resolution on TCDC and decided to embark on technical cooperation in pharmaceuticals among ASEAN countries. Now referred to as Technical Cooperation Among Countries (TCAC), this approach has enabled ASEAN countries to develop their pharmaceutical sectors much more rapidly and efficiently than if each country had acted alone. Strong and sustained cooperation among ASEAN countries directed by designated national coordinators from each country has demonstrated the effectiveness of the TCAC approach in solving common problems and promoting mutual development.

Implementation

The Project has been considered as an ASEAN collaborative project under the ASEAN sub-committee on health and nutrition since 1986. Countries in ASEAN are included in two of WHO’s Regional Offices, the South-East Asian Regional Office (SEARO), covering Indonesia and Thailand, and the Western Pacific Regional Office, (WPRO), covering Brunei Darussalam, Malaysia, the Philippines, Singapore and Viet Nam. World Health Organization collaboration in the Project has been led by WPRO. The responsibility for coordinating activities is shared on an equitable basis among the countries, taking into account different country situations and rapid development in the various fields in the countries. National coordinators are designated as the focal points for project implementation in their respective countries, and are responsible for all aspects of project coordination, from implementing activities through to facilitating ASEAN-wide adoption of the results and planning future areas of technical cooperation in collaboration with WHO. A total of 15 meetings on Technical Cooperation among ASEAN countries in Pharmaceuticals have been held in capital cities of ASEAN countries, with the collaboration of UNDP and WHO (see Annex 1). Brunei Darussalam joined ASEAN in 1985, and joined activities in the pharmaceuticals project in 1986. Viet Nam joined in 1995 and attended the 15th meeting in 1996. Cambodia, the Lao People’s Democratic Republic and Myanmar are currently observers.

At the first meeting, in Jakarta, November 1979, 16 problem areas in pharmaceuticals with objectives and relevant activities for technical cooperation were discussed, and seven areas for possible joint activities were identified. Funding constraints meant that six main areas were finalized for activities:

• exchange of information on drugs and essential drugs list, including exchange of information on drug regulatory matters;
  

• drug supply and management, including clinical pharmacy, hospital pharmacy management and strengthening of communication, information and education on medicine to the community;
  

• development, production and utilization of regional standards and reference substances, including standardization, quality control and utilization of herbal medicines;
  

• Good Manufacturing Practices (GMP);
  

• drug evaluation and control; and
  

• Quality assurance.

 

Exchange of information on drugs and essential drugs list

Access to drug information is important for effective and efficient drug management and control. Such information includes the registration status of drugs and regulatory actions taken by governments to withdraw, ban or restrict drugs in their countries on grounds of safety or serious adverse reaction. Among ASEAN countries, systems for storage, dissemination and utilization of information vary. In some cases, local information on drug usage is incorporated into the government drug management and inventory control system. Elsewhere, pre-existing information from overseas is combined with local information on drugs for registration and drug management and control on a national scale. The first two phases of the Project dealt with the need to make exchange of information among ASEAN countries easier. Phase III saw the establishment of a training centre to improve national-level drug information capabilities.

Exchange of Information on Drug Regulatory Matters

Standard formats for exchanging information on drug regulatory matters were needed to facilitate transfer of knowledge and information within and between ASEAN countries.

Training and exchange of expertise in drug supply and management

When the Project began, some ASEAN countries had poor technical capabilities in drug supply management, while others did not have a well-organized structure for procurement and distribution of drugs. Such capabilities are needed at both central and peripheral levels. In the early phases, training was confined to central level drug supply management. In Phase III, training at the peripheral level covering health centres, rural and other static clinics, and maintenance of vaccine cold chain, was emphasized.

Clinical pharmacy

Clinical pharmacy practice can contribute to improved patient treatment and compliance. As the pharmaceutical sector develops, pharmacists become more involved in pharmacy practice in a clinical setting, thus training for ASEAN pharmacists was important to help them keep pace with changes in the pharmaceutical sector.

Hospital Pharmacy Management

Hospital pharmacies and their services play an integral role in the delivery of medical care by hospitals. In rural hospitals, the introduction of preventive health programmes had created additional responsibilities for pharmacies in drug supply administration, and pharmacists needed training to manage their departments effectively to make this new approach work. Training was carried out through attachments in hospitals and by preparing and using guidelines on Good Hospital Pharmacy Practices and Management (1990). Experiences of hospital pharmacy management covered acquisition, drug distribution systems, drug purchasing, manufacturing and quality control.

Strengthening of Communication, Information and Education on Medicine to the Community

Education of the public is essential to ensure that medicines are taken correctly, to minimize wastage and to prevent misuse or possible adverse effects. Consumer education forms part of the strategy to promote the rational use of drugs. More modern and sophisticated means of communication were needed among ASEAN countries to achieve effective results.

Development, production and utilization of regional standards and reference substances

Reference substances and standards are essential for all aspects of laboratory quality control, evaluation and testing. Efforts by ASEAN countries to produce standards individually were hampered by difficulties in obtaining sufficient quantity and quality of bulk materials and reference substances. The need for reference substances is greater for higher levels of quality assurance as the number of quality control tests increases. In order to conduct quality control analysis economically and in a timely manner, ASEAN reference substances had to be established and made available.

Standardization, Quality Control and Utilization of Herbal Medicine in ASEAN countries

The use of herbal medicines in all ASEAN countries is stimulated by the need to increase health care coverage and the need to utilize local resources. Problems faced in the use of such products include counterfeit preparations, confusion in names and identification, use of immature plants, improper combinations of chemicals during preparation and contamination with heavy metals. Standardization and improvement of quality control in preparation of herbal medicines was considered crucial to making them safe.

Good Manufacturing Practices

The manufacture of consistently uniform batches of quality drugs requires adherence to proper practices in manufacturing, accompanied by control tests on raw materials, intermediates and finished products. In 1969, WHO formulated guidelines for good practices in the manufacture and quality control of drugs, referred to as Good Manufacturing Practices (GMP). To implement GMP at country level, the guidelines have to be adapted by national regulatory authorities to meet the countries' needs and specific national requirements, in accordance with the general guidelines. Guidelines for factory inspections to determine compliance with GMP are also needed to ensure that local manufacturers can implement GMP of acceptable standards, thus facilitating a system for licensing local manufacturing facilities in ASEAN countries. These were also used in updating and improving existing regulations. Compliance with GMP by local manufacturers has increased, thereby promoting the use of locally-produced drugs.

Drug evaluation

Some ASEAN countries had already introduced legislation requiring assessment or evaluation of drugs prior to release, and also of drugs already on the market, to ensure that drugs were safe and effective. Others had no direct system of drug registration. Whatever the situation, all ASEAN countries urgently needed to improve existing drug evaluation procedures, both for new drugs and also for those already on the market.

Quality assurance

National drug quality control laboratories are necessary to ensure that only safe and effective drugs of acceptable quality are marketed. Before the Project began, the capabilities of drug control laboratories among ASEAN countries varied, depending on financial resources and the responsibilities of these laboratories under the drug regulatory mechanisms in force. Quality control laboratories in most ASEAN countries had inadequate facilities and limited human resources. As well as upgrading skills, collaboration among laboratories to avoid duplicating efforts and to lead to standards for particular products on the market was encouraged.

Phase I received funding from UNDP (two activities) and WHO (four activities). All activities for Phase II and Phase III were funded by UNDP. At the end of Phase III, the ASEAN Working Group on Technical Cooperation in Pharmaceuticals was informed that UNDP support would be concentrated in other areas and would not continue for the ASEAN project. To ensure that activities continued, the Action Programme on Essential Drugs (DAP), WHO Headquarters, provided technical and financial support. In 1992, the Japan Pharmaceutical Manufacturers Association (JPMA) began to support activities on the production and utilization of regional standards and reference substances. Contributions from JPMA were not only monetary, but included the donation of bulk pharmaceutical materials and books, and the provision of training fellowships in quality control.

The basic mechanism for the Project has been the transfer of knowledge and expertise. Training opportunities in more developed countries have given nationals of ASEAN countries access to the latest technologies through fellowships, study tours and expert meetings. This knowledge and expertise has then been transferred within and among ASEAN countries.

Activities were implemented in four phases, Phase I (1982-1983), Phase II (1984-1986), Phase III (1987-1991) and Phase IV (1992-1996). In Phases I and II, emphasis was placed on establishing mechanisms for exchanging information on various aspects of drug supply and management, developing guidelines for drug evaluation and developing adequate quality control laboratories as well as the production of reference substances. The concept of regional training centres to meet the need for more training within ASEAN countries to achieve greater self-reliance was developed in Phase III and became the main thrust of Phase IV. These centres were generally established by choosing and designating a particular institution or department in an ASEAN country which could be developed to conduct training courses in specific fields, with minimal support in the form of materials and manpower if necessary. Phase IV priorities were ASEAN training centres for various aspects of quality assurance (drug evaluation, good manufacturing practices, quality assurance and non-pharmacopoeial analytical methods and production and utilization of reference substances) and hospital pharmacy.

Problems that have hampered Project activities include the difficulty experienced by smaller countries in identifying and nominating candidates for training coupled with limited training personnel; uneven scheduling of activities throughout the year resulting in crowding of activities towards the end of the year; and slow response times hampering efforts to identify suitable institutions for Fellowship placement.

• Exchange of information on drugs and essential drugs list, including exchange of information on drug regulatory matters.
  

• Drug supply and management, including clinical pharmacy, hospital pharmacy management and strengthening of communication, information and education on medicine to the community.
  

• Development, production and utilization of regional standards and reference substances, including standardization, quality control and utilization of herbal medicines.
  

• Good Manufacturing Practices (GMP).
  

• Drug evaluation.
  

• Quality assurance.
  

Exchange of information on drugs and essential drugs list

• Draft standard formats were prepared to facilitate exchange of information on: approval of new chemical entities, new indications, new routes of administration; significant drug changes; and significant adverse reactions.
  

• Software was developed in Malaysia for computerized data banks for drug registration and information systems using the data elements defined above to serve as the basic guidelines in any drug information exchange.
  

• A comparative list of essential drugs used in ASEAN countries was prepared to facilitate selection of drugs by government health care sectors.
  

• National drug information collection, evaluation and dissemination systems were updated or established in ASEAN countries. Indonesia and Thailand participated actively in the WHO International Drug Monitoring Programme and Malaysia became the 31st Member State to join the programme. Singapore initiated a national adverse monitoring system in 1985 as did the Philippines in 1995.
  

Exchange of Information on Drug Regulatory Matters

• The ASEAN TCDC Information Exchange Proforma for Drug Regulatory Matters was adopted.
  

• The form for Exchange of Information on Significant Drug Matters was endorsed.

Drug supply and management

• Advanced drug supply methodology was acquired through exposure to computerized drug supply management systems in developed countries. Human resources capabilities were strengthened through fellowships conducted both within and outside ASEAN. Training was found to be very useful, especially for countries that did not have centralized procurement and distribution systems coupled with effective quality control.
  

• The ASEAN Manual on peripheral drug supply management was produced and adopted for use.
  

• More efficient and improved drug supply systems to ensure the availability of quality drugs while at the same time preventing overstocking and wastage of drugs were introduced at the peripheral level.

Clinical pharmacy

• Human resource capabilities in clinical pharmacy services were strengthened to improve patient compliance and promote rational use of drugs.
  

• Fellowships to study clinical pharmacy in developed countries enabled further development of existing clinical pharmacy services.
  

• Workshops in clinical pharmacy were held within the region.
  

• Regional training centres for Clinical Pharmacy and Improvement of Communication Skills of Pharmacists and Pharmacy Staff were established in Singapore, jointly coordinated by Brunei Darussalam and Singapore.
  

• Training manuals for Clinical Pharmacy and Improvement of Communications Skills of Pharmacists and Pharmacy Staff were prepared.
  

• The first training course on improvement of communication skills for pharmacists was held in Singapore.

Hospital Pharmacy Management

• Human resource capabilities were strengthened through training within and outside ASEAN.
  

• Guidelines on Good Hospital Pharmacy Practice and Management were prepared and adopted for use in national level hospitals. These guidelines cover: administration; facilities; drug distribution and control; drug interaction; assessing rational drug therapy; research; and quality assurance.

Strengthening of Communication, Information and Education on Medicine to the Community

• Fellows were trained both within and outside ASEAN to strengthen communication skills of pharmacists and improve information on drug use provided to the public.
  

• Patient information leaflets, posters and video tapes were produced and distributed to all ASEAN countries.

Development, production and utilization of regional standards and reference substances

• Human resource capabilities were strengthened through training in chemical and microbiological assay of reference substances.
  

• A total of 92 ASEAN Reference Substances (ARS) were established.
  

• Collaboration on production and utilization of reference substances made more reference substances available. In some ASEAN countries, development of these reference substances has helped overcome problems in procuring high-cost reference standards and improved the frequency of quality control operations.
  

• A training centre for Production and Utilization of Regional Standards and Reference Substances was established in Thailand.
  

• A booklet listing 65 ARS was published and distributed to ASEAN countries.
  

• Twelve reference substances were supplied by JPMA.
  

• Thirty-nine ARS were re-examined during Phase IV.

Standardization, Quality Control and Utilization of Herbal Medicine in ASEAN countries

• A manual on cultivation, production and utilization of herbal medicines in primary health care was developed.
  

• GMP guidelines for the manufacture of herbal medicines were adopted.
  

• Volume I of Standard ASEAN Herbal Medicines, consisting of 36 monographs on herbal medicine, was printed and distributed.
  

• 14 draft monographs of crude drugs were prepared.
  

• 40 herbaria for ASEAN member countries were prepared.

Good Manufacturing Practices

• ASEAN Good Manufacturing Practices (GMP) Guidelines (2nd edition, 1988).
  

• ASEAN Good Manufacturing Practices (GMP) Guidelines (3rd edition, 1996).
  

• ASEAN Manual for GMP Inspection published in 1988, then revised during Phase IV with an emphasis on auditing.
  

• A regional training centre was established in Indonesia to train ASEAN nationals to use these guidelines effectively in the implementation of GMP in their countries.
  

• Training in updating requirements for GMP of biological and sterile products was held in the United Kingdom.
  

• Participants were trained to conduct national in-service courses on the methodology of GMP audit in their respective countries.

Drug evaluation

• Policies and guidelines on the evaluation and registration of new drugs, over-the-counter drugs, fixed-dose combination drugs, herbal/traditional drugs and labelling requirements were formulated and adopted.
  

• National systems for monitoring adverse drug reaction through collecting, evaluating and disseminating information were developed.
  

• The Operation Manual on Drug Evaluation and Control for the ASEAN region was prepared and adopted for use by ASEAN countries.
  

• Expertise on drug evaluation was strengthened through study tours, group training, meetings and workshops, both within and outside the region.
  

• A regional training centre for Drug Evaluation and Control was established in the Philippines.
  

• The Report on Technical Meeting on Re-evaluation Criteria for registered products was adopted.

Quality assurance

• Human resource capabilities were strengthened through fellowships and group training both within and outside ASEAN.
  

• A workshop on quality control of drugs with no official method of analysis was held to broaden the technical basis of ASEAN quality control personnel through the exchange of experience in this area.
  

• Quality control laboratories were improved, making it possible to tackle problems related to drug quality assurance, e.g., counterfeit drugs and sub-standard drugs, and also to extend quality vigilance in some countries.
  

• A regional training centre on Strengthening of Quality Assurance and Non-Pharmacopoeial Analytical Methods was established in Malaysia.
  

• Training in Good Control Laboratory Practices was undertaken in Sweden and The United Kingdom. Staff were trained in three aspects of laboratory control; the WHO Basic test scheme to further improve drug quality at peripheral level, guidelines for Good Control Laboratory Practice (GCLP), and non-pharmacopoeial analytical methods.
  

• The report of the Intercountry Experts Meeting on ASEAN Good Control Laboratory Practices was adopted.

Phase V: Plans for 1997-2001

As earlier elements of the Project become self-sustaining, new emphases for Phase V will be on analytical methods for biological products such as vaccines, anti-toxins and insulin, biological testing and expert meetings on counterfeit drugs, which are a major problem in the region. Project activities will continue to aim at self-sufficiency in the pharmaceutical sector.

Future development objectives for the ASEAN Pharmaceuticals Project are to:

• further strengthen the pharmaceutical sector to ensure supply of safe, efficacious and quality drugs in furtherance of the overall objectives of health for all beyond the year 2000; and

• achieve self-reliance in human resource development within the countries of the region in specific fields.

• ASEAN Good Manufacturing Practices (GMP) Guidelines (1st edition, 1984)
  

• ASEAN Manual on peripheral drug supply management (1988)
  

• 14 draft monographs for crude drugs (herbal medicines) (1988)
  

• ASEAN Manual for GMP inspection (1988)
  

• Manual on cultivation, production and utilization of herbal medicines in primary health care (1990)
  

• Videotape on proper use of medicine (1990)
  

• Guidelines on Good Hospital Pharmacy Practice and Management (1990)
  

• ASEAN Operational Manual on Drug Evaluation and Control (1991)
  

• GMP Guidelines for the manufacture of herbal medicines (1993)
  

• Volume I of Standard ASEAN Herbal Medicines consisting of 36 monographs on herbal medicines (1993)
  

• Report on Intercountry Expert Meeting on ASEAN Good Control Laboratory Practices (1994)
  

• Report on Technical Meeting on Re-evaluation Criteria for registered products (1994)
  

• Standard format for exchange of information on drug regulatory matters (1994)
  

• 92 ASEAN reference standards established, of which 65 ARS included in a booklet distributed to ASEAN countries (1996).
  

• ASEAN Good Manufacturing Practices (GMP) Guidelines
  (3rd edition, 1996)
  

• Training Manuals for Clinical Pharmacy and Improvement of Communication Techniques for Pharmacists and Pharmacy Staff (1996)
  

• Patient information leaflets, posters and video tapes to strengthen consumer education on rational drug use published and distributed to ASEAN countries
  

• 20 non-pharmacopoeial analytical methods
  

• 40 herbaria prepared for ASEAN countries
  

• 743 staff trained through ASEAN courses and fellowships

As with so many other aspects of development, creating self-sufficiency is the key to sustainability. ASEAN countries have become more self-sufficient in many areas of pharmaceutical manufacture, supply and management as a result of this Project. However, total independence is still a long way off, and work needs to continue if the benefits of the first 15 years of the Project are to be fully realized.

Project activities have contributed to improving many aspects of the pharmaceutical sector in ASEAN countries. Progress has been made towards greater self-sufficiency in each of the six main activity areas. Human resource development in drug supply management and quality assurance has been upgraded significantly. Compliance with GMP has helped to ensure wide acceptance of products from ASEAN manufacturers. The development of ASEAN Reference Substances has contributed to greater capabilities in quality assurance. Problems in implementing Project activities have been noted and will be addressed if the Project continues.

Governments, through their national coordinators, have shown strong dedication and support in implementing planned activities. Key factors in the success of the Project have been:

• the political will of ASEAN nations to achieve common goals of social and economic development based on provision of quality health care services;
  

• mutual understanding, cooperation, support and sharing of experiences;
  

• careful selection of target fields based on the needs of ASEAN countries;
  

• use of an appropriate vertical and horizontal technology transfer approach;
  

• selection of technical areas of national interest and competence and further developing them, and sharing the fruits of this development;
  

• designation of national coordinators for ASEAN activities;
  

• active involvement of WHO as executing agency and general coordinator; and
  

• support of UNDP, WHO and JPMA.

Plans for Phase V (1997-2001) include the continued strengthening of human resource development at regional training centres and expert meetings on recent developments, with a gradual shift towards quality assurance of biological products.

The effects of the Project will become more far-reaching as ASEAN expands. If funding is found to continue the Project into the next century, newcomers to ASEAN (Cambodia, the Lao Peoples Democratic Republic and Myanmar are currently observers) will benefit from the expertise already gained during the first four phases of the Project, and contribute their own expertise to mutual development in the pharmaceutical sector in ASEAN. By finding the support to make the next step, ASEAN countries can come closer to the goal of self-sufficiency in all aspects of the pharmaceuticals sector.

After the first meeting in 1979, where national coordinators were designated as the focal points for project implementation in their respective countries, subsequent meetings held enabled national coordinators to:

• discuss implementation of the project and decide on corrective action if any;
  

• receive reports and recommendations of smaller expert committee and groups convened to deliberate on specific technical matters;
  

• adopt manuals/guidelines presented by such groups for application in ASEAN countries; and
  

• on specific occasions, to review the project and to formulate further plans for technical cooperation.

In April 1986, the project was considered as an ASEAN collaborative project under the ASEAN Sub-committee on Health and Nutrition (ASCH&N) and the meetings were then renamed as Meetings of ASEAN Working Group on Technical Cooperation in Pharmaceuticals. Brunei Darussalam participated for the first time in the working group meeting in December 1985 after joining ASEAN, and its nationals participated in project activities in 1986. In July 1995, Viet Nam joined ASEAN and participated for the first time in the 15th working group meeting in Manila, June 1996.

First meeting, 26-29 November 1979, Jakarta, Indonesia

The meeting in Jakarta discussed the possibilities for technical cooperation among ASEAN countries in the field of pharmaceuticals. The meeting identified 16 problem areas, objectives and relevant activities for technical cooperation. It covered general problems on drug legislation, registration, licensing or other control measures for drugs, drug evaluation, licensing of manufacturers, wholesalers and distributors of drugs, drug inspection, laboratory services, standards and reference substances, quality assurance, post-marketing surveillance, information on drugs, development of essential drugs lists, exchange of technical expertise and technical know-how, pharmaceutical raw materials and veterinary products. The meeting selected and decided on seven possible joint activities: exchange of information on drugs; training and exchange of expertise in drug supply and management; development, production and utilization of regional standards and reference substances; exchange of information on essential drugs lists; development of practical guidelines for the implementation of Good Manufacturing Practices (GMP), drug evaluation and control; and development of adequate control laboratories. A Task Force group was formed to undertake a feasibility study for implementation.

Second meeting, 19-20 August 1980, Manila, Philippines

The meeting considered the reports of the Task Force Group and formulated the terms of reference and plans of action with a proposed budget for each of the seven agreed activities.

Third meeting, 7-9 December 1981, Kuala Lumpur, Malaysia

At the third meeting, a project document for UNDP funding for 1984-1986 with a total cost of US$650 000 was adopted and submitted for approval by ASEAN Governments with WHO as the executing body. Because of UNDP's budgetary constraints, the project was divided into two phases. For Phase I (19982-1983) the budget was US$200 000, and for Phase II (1984-1986) the budget was US$450 000. Due to problems in financing, the total number of activity areas was reduced from seven to six, and plans of action finalized.

Fourth meeting, 23-25 August 1983, Singapore

The meeting reviewed the progress of implementation of activities under Phase I (1982-1983) and formulated workplans for Phase II activities (1984-1986). The meeting adopted 12 ASEAN Reference Substances.

Fifth meeting, 11-13 December 1984, Bangkok, Thailand

The meeting adopted the ASEAN GMP Guidelines and the ASEAN Manual for Inspection. Eight ASEAN Reference Substances were adopted.

Sixth meeting, 19-21 December 1985, Jakarta, Indonesia

The sixth meeting considered the Phase III project document prepared by the Task Force Group covering 10 areas of technical cooperation for 1987-1991.

Seventh meeting, 10-11 December 1986, Brunei Darussalam

A terminal tripartite review of Phase II with UNDP was held prior to the meeting. Project implementation was found to be satisfactory and continuing activities into Phase III was recommended. The meeting adopted six ASEAN Reference Substances and accepted the reports and recommendations of the workshops on quality control procedures for drugs without official methods of analysis, on drug evaluation and the seminar on drug supply management at peripheral level. All ten areas of technical cooperation covering Phase III of the project were endorsed.

Eighth meeting, 20-23 June 1988, Kuala Lumpur, Malaysia

A tripartite review was held to assess the progress of the first year implementation of Phase III. In view of new developments in WHO/HQ covering a similar activity, it was agreed with consensus that the activity coordinated by Brunei Darussalam entitled "Development of an Essential Drug Information Manual" be dropped and replaced by the activity "Development of Clinical Pharmacy".

Ninth meeting, 8-11 May 1990, Manila, Philippines

The meeting noted the overall satisfactory and improved level of implementation of the project during the period July 1988 to December 1989.

Tenth meeting, 25-28 February 1991, Singapore

The meeting finalized the formulation of work plans and the programme for continued technical cooperation among ASEAN countries and approved continuing activities proposed for Phase IV. The project document for Phase IV covering the period 1992-1996, with a proposed budget of US$1 158 700, was presented and adopted.

Eleventh meeting, 17-20 December 1991, Bangkok, Thailand

It was agreed that, while the seven areas were considered essential, it was necessary to prioritize activities to facilitate possible funding by DAP/HQ and to speed up the implementation of the activities should funds from other sources become available. Hence, emphasis was given to activities in drug evaluation, quality assurance and hospital pharmacy. The meeting adopted 20 new ASEAN Reference Substances, the Standard for ASEAN Herbal Medicine (SAHM) and the Operational Manual of Drug Evaluation and Control for ASEAN. The tripartite meeting (terminal) noted the very satisfactory implementation of activities in Phase III and the favourable and positive impact of project activities in ASEAN countries.

Twelfth meeting, 30 November-3 December 1992, Brunei Darussalam

The meeting endorsed the workplan for 1993 activities and the content of the report of the 12th meeting, including the list of designated coordinators/national agencies for project implementation, the list of contact persons for the exchange of information on drug regulatory matters and the form for exchange of information for significant drug matters.

Thirteenth meeting, 6-9 December 1993, Jakarta, Indonesia

The meeting adopted the guidelines for GMP for manufacture of herbal medicines and 15 new ASEAN Reference Substances.

Fourteenth meeting, 12-14 December 1994, Kuala Lumpur, Malaysia

The meeting adopted the Report on ASEAN Technical Meeting on Re-evaluation Criteria for registered products, the Report of the Inter-country Expert Meeting to Consider and Adopt ASEAN Good Control Laboratory Practices, and ASEAN TCDC Information Exchange Proforma for Drug regulatory Matters.

Fifteenth meeting, 24-26 June 1996, Manila, Philippines

The meeting adopted the revised ASEAN Good Manufacturing Practices Guidelines (third edition, 1996), two non-pharmacopoeial analytical methods, the Training Manual for Clinical Pharmacy, the Training Manual on Communication Techniques for Pharmacists and Pharmacy Staff, ASEAN Reference Substances, the report of the First Meeting of the Working Group of the Bi-Regional Technical Cooperation Among Developing Countries in Essential Drugs, and the Phase V project document, 1997-2001.

Annex 2: Objectives of WHO/DAP

The objectives of the WHO Action Programme on Essential Drugs are:

• to assist Member States in formulating comprehensive national drug policies in support of national health services;
  

• to assist Member States in strengthening their technical, structural and human resource capabilities in selection, supply, distribution, local production, quality assurance, legislation, regulation, economic analysis, modes of financing, and rational use of drugs;
  

• to assist Member States in implementing and evaluating all components of national drug policies and essential drugs programmes;
  

• to promote and facilitate the transfer of knowledge, expertise and technology; and
  

• to play a major international and national advocacy role in support of the essential drugs concept and the need for and methods of achieving a more rational use of drugs.

Annex 4: List of 36 Common ASEAN Herbal Medicines with standardized monographs

Annex 5: Participation of Member States in fellowships and training in each activity area (fellowships and group training only) (continued)

Annex 6: List of 40 herbaria

Annex 7: List of 20 Non-Pharmacopoeial Analytical Methods

1. Analysis of Erythromycin Stearate tablet (HPLC Assay).

2. Analysis of Ambroxol Hydrochloride tablet (UV Assay).

3. Solid phase extraction and HPLC method for the simultaneous analysis of basic drugs in syrup formulation.

4. Analysis of copper, lead and mercury in traditional herbal medicines.

5. Analysis of minerals in multivitamin preparations.

6. Analysis of medicated oil, cream and ointment by gas chromatography.

7. Analysis of oil and water soluble vitamins in multivitamin preparations (tablets/capsules, oral solution and injection).

8. Analysis of cough mixtures by HPLC.

9. Analysis of amino acids in multivitamin preparations.

10. Microbiological assay of Cefaclor.

11. Microbiological assay of Fosfomycin.

12. Microbiological assay of Spiramycin.

13. HPLC analysis of Dexbrompheniramine maleate and Pseudoephedrine Hydrochloride tablet.

14. Assay of zinc pyrithione in anti-dandruff shampoo.

15. Assay of chlorocresol in Heparin preparations
    (5 000 IU/ml).

16. Assay of Oxytocin using HPLC method.

17. Determination of potency of Thrombin preparations using normal human plasma.

18. Quantification of serum calcium in Calcitonin preparations using UV method.

19. Determination of anti-factor Xa activity in low molecular weight Heparin preparations.

20. Limit tests for lead, arsenic and mercury in traditional medicines.