Saturday, October 15, 2016

Pharma regulatory improvements in Indonesia

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Indonesia has amended its pharmaceutical registration requirements. The National Food and Drug Supervisory Agency (BPOM) issued Regulation No. 17 of 2016 (Amendment) amending its 2011 regulation Criteria and Procedures for Drug Registration (Regulation) in August 2016.

The Amendment seeks to simplify drugs registration procedures. All drugs must be registered to obtain a drug distribution permit. There are 3 registration categories:
1. New registrations (that is all new drugs and biotherapeutic products, including biosimilars, generic drugs and other pharmaceutical products)
2. Variant registrations (such as reformulations and new compounds); and
3. Re-registrations and extensions.

The Amendment focuses on major variants where there is no need for further quality and efficacy testing. This applies to new formulations for example. In those cases, the the pre-registration processes to examine the various necessary factors for a new drug registration are no longer required, in essence because the drug is a mere reformulation of an existing one, that has been through those procedures.

Processing times for BPOM to register various categories of drugs have also been accelerated.  This applies to categories such as major variants like reformulations,  re-registrations, along with drugs for serious and life threatening illnesses and orphan drugs.

The intention is to improve speed to market of important pharmaceutical products in Indonesia by removing unnecessary procedural barriers.  

Meanwhile Indonesia's Parliament is debating a far more comprehensive
Draft Bill on Drugs and Foods Supervision which is intended to improve the quality, safety and efficacy of drugs and foods across the country. It proposes to do this by bringing the current patchwork of rules under one law. More rigourous distribution rules are driven by the recent fake vaccines scandal (see here).

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