Drug Efficacy Safety Implementation

The requirement that drugs be both effective and safe did not become law until 1962. The Kefauver-Harris amendment to the Food, Drug, and Cosmetic Act passed in 1962 required the FDA to review all drugs released after 1938 for effectiveness as well as safety. This program established the Drug Efficacy Study Implementation (DESI) and the job was assigned to the National Academy of Sciences—National Research Council, which reviewed the data presented for each drug that had been submitted to the FDA. 

Regulatory implementation—improve control on safety and efficacy of drugs and the distribution channels develop better coordination between local, regional, and central authorities... 

According to the Drug Act 1967 (B.E. 2510), cill pharmaceutical products must be submitted for registration prior to their import or manufacture. However, after the implementation of Ministerial Order No. 14 (B.E. 2532) in 1989, pharmaceutical products imported for clinical studies and other special purposes (i.e., donation, charity, analysis, exhibition etc.) have been exempt from product registration. Nonetheless, clearance is still mcmdatory. Submission of information or documents supporting the efficacy eind safety of pharmaceutical products and vaccines to justify approved for import is still required. 

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