NPRA of Malaysia Issues Directive on Pre -Registration Test Results of Natural Products

On 12 May 2020. National Pharmaceutical Regulatory Division (NPRA) has issued a directive by the Director of Services Pharmacy pertaining to pre-registration test results of natural products from private laboratories.

Directive  No. 8 of 2020 states that the Director has agreed to the acceptance of pre-registration test results of natural products from private laboratories approved by the National Pharmaceutical Regulatory Division (NPRA) and local manufacturers’ quality control laboratories as per the requirements of  No. (8) BPFK / PPP / 07/25 Jld.4.
All product registration holder is directed to comply with these requirements.

Product Registration Holder (PRH) must submit test results in the form of a certificate of analysis (CoA)
for evaluation purposes through the Quest 3+ system.

There is no need to submit pre-registration samples to the NPRA laboratory.

The directive also includes process work and acceptance criteria for decisions on product testing.
There are no changes to the fees and application period for the evaluation of natural product registration.
The directive has also included the list of NPRA accredited private laboratories on their website.

Local manufacturers may issue a certificate of analysis for their own products.
Imported products must obtain an analytical certificate from NPRA panel laboratories.
The type of tests are required to be carried out are listed in the directive and shall be specified in the analytical certificate.
For further information, please refer to https://www.npra.gov.my/easyarticles/images/users/1048/gambar/DIREKTIF-PENERIMAAN-KEPUTUSAN-PENGUJIAN-PRA-PENDAFTARAN-PRODUK.pdf