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.