Vietnam’s Ministry of Health has proposed extending Good Manufacturing Practices (GMP) standards to high-risk drugs under its draft circular to revise Clause 10, Article 4 of Circular 35/2018/TT-BYT, local media reported.
Current regulations apply GMP standards to drugs containing beta-lactam antibiotics such as penicillins, cephalosporins and penems, as well as cytotoxic drugs, contraceptive hormones, vaccines and biologics. These drugs must be produced in GMP-compliant facilities with dedicated production lines and equipment to prevent contamination.
Under the latest circular, anti-cancer drugs, sex hormones and other highly active pharmaceuticals not previously covered will be subject to risk assessments based on guidelines from the European Medicines Agency and the World Health Organization.
The proposal also allows drugs produced in facilities from countries listed under the government Decree 54/2017/ND-CP, and approved by agencies such as the U.S. Food and Drug Administration, European Medicines Agency, Australia’s Therapeutic Goods Administration, Japan’s Pharmaceuticals and Medical Devices Agency or Health Canada, to be recognized under GMP certification. (Suc Khoe Doi Song)