On 2 July 2020, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has agreed to the implementation evaluation of bioequivalence (BE) study screening requirements as per instruction letter : NPRA.600-1 / 9/13 (3).
The instructions set out by the Director of Pharmaceutical Services Number 5 of 2016 indicates that inspection reports for BE studies conducted in the USA, Canada and Europe from certain regulatory bodies in Europe are accepted.
In line with current developments and increasing volume inspection of BE study conducted abroad, there is a need to implement a new mechanism for determining the screening requirements of a BE study. The mechanism will be in accordance with international practice and does not affect safety aspects, product quality and effectiveness.
The evaluation of the BE study examination requirements was conducted based on the concept of Risk-based Assessment for the BE study conducted by: i) Study Centers that are not listed in the BE or ii) Study Centers that are within the validity period of the BE NPRA Study Centre‘s Compliance Programme.
The notice also listed out the documents that are required for screening purposes. Evaluation of the BE study screening is based on the information obtained from time to time relying on the latest information and needs.
The notice also entails the decision process of the BE study screening where NPRA reserves the right to conduct inspections on the study site involved if the results are unsatisfactory.
More information could be accessed here:-
ARAHAN PENGARAH PERKHIDMATAN FARMASI BILANGAN 12 TAHUN 2020:DIREKTIF PELAKSANAAN- PENILAIAN KEPERLUAN PEMERIKSAAN KAJIANBIOEKUIVALENS (BE)