Post-marketing Control
To further ensure quality, safety and efficacy of the approved drug products, the marketed products are regularly sampled for testing at the drug analysis laboratory of the Medical Sciences Department, Ministry of Public Health. In addition, contracts have been signed with some qualified laboratories of local universities to assist in solving the problems of drug quality. The surveillance tasks involve the following ;
- Inspection of GMP compliance at manufacturing sites;
- Monitoring of manufacturing process changes to ensure no adverse effects on the safety or efficacy of the medicines;
- Monitoring of the use of marketed drugs for unexpected health risks, taking action if risks are detected by informing the public, investigating the cause and removing the drugs from the market;
- Receiving and handling of complaints;
- Safety monitoring program for new drugs;
- Re-evaluation of pharmaceutical products.
Re-evaluation of Pharmaceutical Products
Even though drugs have been strictly examined for their quality, efficacy and safety before being approved for marketing, chronological consumption data in a large population, new findings and pharmaceutical progress may later reveal very serious side effects that were not previously seen. A balance between efficacy/benefit and potential risks or serious adverse reactions is frequently questioned, especially those in combination. The Drug Committee in 1991 appointed a subcommittee to evaluate the registered products. Some criteria have been set and the evaluation process has been ongoing.
