BPOM Simplifies Drug Registration Process

The Head of the National Food and Drug Supervisory Agency (“BPOM”) has issued Regulation No. 17 of 2016 (“Second Amendment”) on the Second Amendment to Head of BPOM Regulation No. HK.03.1.23.11.08481 of 2011 on the Criteria and Procedures for Drug Registration (“2011 Regulation”).
 
The Second Amendment sets out a number of measures in a bid to improve the oversight of the drugs industry, as well as to simplify the drugs registration process, which is a requirement for the securing of a drug-distribution permit from the BPOM. The main changes which have been incorporated under this Second Amendment are: