Pilot collaborative registration procedure for SRA-approved medicines

Feb 18, 2016 | WHO PQ

What is collaborative registration

The WHO PQ has announced a pilot collaborative registration procedure for SRA-approved medicines. The principle of the pilot is similar to that of WHO PQ’s already existing collaborative registration procedure of WHO-prequalified products, but being applied to medicines that are SRA-approved. Regulatory dossiers for a product that had been successfully submitted and accepted to WHO PQ, or to an SRA in this case, can be sent to participating NMRAs, who will then have the assurance that the dossier in question will have already been approved by a reputable regulatory authority. Participating National Medicines Regulatory Authorities (NMRAs) would be expected to give their decision on registration within 90 days of accepting the dossier’s submission. The idea is to save time and resources that are taken up within local regulatory processes, and ensure that good quality medicines are made available sooner to those who need them.

How to participate

Detailed information on the pilot procedure and the required conditions for taking part can be found here.

Products being included in this pilot are medicines for HIV, TB, and antimalarials, as well as RH products such as contraceptives and maternal health medicines. It is open to both generic and innovator products. Any pharmaceutical companies interested in participating should contact WHO PQ directly at prequalreg@who.int.