Pharmaceutical Issues
The Food and Drug Administration also works in collaboration with international organizations relating to the issues of pharmaceutical approval processes. FDA officials participate in numerous conferences, meetings, workshops and training programs sponsored by professional societies, international organizations or the private sector. The participation not only gives us opportunities to present our position and viewpoints, but also to gather information which will be very helpful for developing our policies and guidelines in the future.
Numerous programs and projects relating to pharmaceuticals are carried out through communication and collaboration with international organizations, for example:
World Health Organization (WHO)
Standard requirements (e.g. product certification, GMP, GCP, GLP, GAP, HAACP, etc.), essential drug list and policy, workshops, training and study visits, and promoting rational use of drugs, etc. The program on essential drugs is an important action program specified in the National Drug Policy. The Thai FDA has closely cooperated with the WHO Action Program on Essential Drugs on the establishment and implementation of its own National Essential Drug List. The List was set up in 1981 and has been regularly reviewed. The Essential Drug List has become more popular and widely used among physicians and pharmacists when the Ministry of Public Health enforces a measure requiring that MOPH hospitals can spend the government budget on the purchase of drugs on the Essential Drug List only.
World Trade Organization (WTO)
Drug trade, expanding world trade, TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement (Doha Declaration), patent law, trade secret law.
The ASEAN Working group on Technical Cooperation in Pharmaceuticals (AWGTCP)
Follow up of resolution adopted at the Thirty-second World Health Assembly (WHA) on Technical Cooperation Among Developing Countries (TCDC), the ASEAN Technical Cooperation in Pharmaceuticals having start in 1982 and set up the annual meeting hosted around by the member country. The cooperation is indeed a very important initiative, which responds to current situation in pharmaceuticals in ASEAN countries as well as the current challenges of globalization. Its objectives are to strengthen the pharmaceutical sector in all ASEAN countries in order to ensure sufficient and regular supplies of effective and safe essential drugs of acceptable quality, and achieve self-reliance in the training of human resources in certain fields.
From the 20 Th ASEAN Working Group Meeting 10 th – 11 th September 2003 has proposed new areas for future collaboration include:
- Proposed concept paper on Drug Safety Programme (Thailand)
- Improving access to needed medicines-The Doha Declaration on Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and public health (WHO/HQ)
- Pharmacoeconomics in drug regulatory activities and pharmaceutical practices (WHO/HQ)
- Strengthening Asian's capacity on Good Clinical Practice (GCP) and clinical trial ( Thailand )
Asia-Pacific Economic Cooperation (APEC) – issues concerning pharmaceutical regulations and requirements for product registration and trade agreements.
Government to Government (G to G) program – strengthening good relationships between Thai and foreign agencies and helping to facilitate and pave exporting routes or expansion for locally-manufactured drug products to countries in Eastern Europe, South Africa and the Middle East.
Convention on Inter n a t i o nal Trade in Endang e red Species of Wild Fauna and Flor a (CITES) – collaboration in banning registration of products containing components from endangered animals, e.g. tiger bones, bear claws, elephant ivory, etc.
Forum for Ethical Reviews in the Asian and Pacific region (FERCAP) – protection of human subjects in clinical trials by strengthening standards and efficiency in ethical reviews of research involving human subjects within the country and throughout the region.
