New Regulation on Drug Registration Criteria and Procedures

Head of the National Food and Drug Supervisory Agency (“BPOM”) has recently issued Regulation No. HK.03.1.23.10.11.08481 of 2011 on the Criteria and Procedures for Drug Registration (“Regulation”), to protect the public from drugs that do not meet drug safety, quality and the use requirements.

The Regulation is an implementation of Article 14 (2) of Minister of Health Regulation No. 1010/Menkes/Per/XI/2008 on Drug Registration, as amended by Minister of Health Regulation No. 1120/Menkes/PER/XII/2008. It also implements Article 36 (4) of Law No. 35 of 2009 on Narcotics.

The Regulation has 60 articles, 12chaptersand 10 appendices. In comparison, Head of National Agency of Drug and Food Control Decree No. HK.00.05.3.1950 of 2003 on the Criteria and Procedures for Drug Registration (“2003 Decree”) consists of 45 articles, 10 chapters and 26 appendices.