PERU (15-SEP-2018): New Bioequivalence Regulation for Peru

On Saturday 15-SEP-2018, the Peruvian government published a complementary regulation, Supreme Decree N° 024-2018-SA, providing the a framework for bio-equivalence (BE) and interchangeability of multi-source drug products.

The 2009 overarching Peruvian law governing drug and other regulated products (Law 29459) already stated that interchangeability studies [i.e. bioequivalence and/or in-vitro bio exemption studies] will be required for the initial marketing approval and/or renewals of drug products, but this was not enforced due to the lack of an specific BE regulation. With the recent publication of decree 024-2018-SA, this limitation is being addressed and the Peruvian regulatory authority (DIGEMID) will start requesting BE studies. However it is worth noting the following:

  • The BE regulation will enter into force only 6 months after its publication (mid March-2019).

  • As of the issuance of the regulation it is mandatory to provide BE studies data (in-vivo) at least for [oral] drug products containing the following drug substances/APIs and strengths: a) Cyclosporine 100mg; and: b) Mycophenolate Sodium 360mg modified release tablets.

  • As of issuance of the regulation it is mandatory to provide at least in-vitro equivalence data for immediate release solid oral dosage forms containing the following drug substances/APIs, strengths and dosage forms: a) Lamivudine 150 or 300 mg tablets; b) Zidovudine 300mg tablets; c) Zidovudine 100mg capsules; d) Lamivudine/Zidovudine 150mg/300mg tablets; and: e) Diazepam 10mg tablets.

  • Other drug products could submit data to demonstrate interchangeability voluntarily. However the regulatory authority will gradually extent the list of product requiring mandatory submission of interchangeability data.

You can download a copy of the full regulation (in Spanish), with bookmarking indexes added by RAFINT, by clicking here.

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