Under Section 62 (1) of the PMRA Act, 2019, a person who intends to place on the market, advertise,
market, manufacture, sell, import, supply, administer or deal in any manner with any medicine or allied substance is supposed to apply to the Authority for a marketing authorization in the prescribed manner.

Medicines registration pathways

The pharmacy and Medicines Regulatory Authority registers medicines through:

1. Normal registration pathway: The normal registration pathway uses the principle of first submitted and first to be reviewed is applied. Through this pathway, full review of quality and clinical information is done. Quality control testing of registration samples is also done. The regulatory time line for registration of medicines through this pathway is 360 days.
2. Fast track registration pathway: The fast track registration pathway does not follow the principle of first submitted first to be reviewed. Applicant pays fees which is double the amount paid for the normal registration pathway. PMRA Fees Schedule is available on this link: Fees Schedule. Guidelines for fast track registration are available on this link: Fast track registration. There are five pathways for fast track registration:

2.1. WHO Collaborative registration procedure (WHO CRP) for WHO prequalified and SRA registered medicines and vaccines: Details for WHO CRP can be are available here Regulatory registration period for WHO CRP is 90 days from the time PMRA accesses reports from WHO CRP Team.

2.2. SRA registered products: Products which are registered in SRA markets can be eligible for this fast tract registration provided the applicant has assessment report from reference authority and provides a consent to PMRA to verify provided reports by the reference authority. Regulatory registration period is 90 days from the time full dossier and reference authority assessment report are provided to the Pharmacy and Medicines Regulatory Authority.

2.3. Products recommended for registration by SADC Regulatory Harmonization initiative, ZAZIBONA: Procedure for fast track registration of medicines is available here. The regulatory registration period for product recommended for registration by ZAZIBONA is 90 days.

2.4. Products recommended for registration by the African Medicines Regulatory Harmonisation (AMRH) Programme Africa: The procedure will be available once AMRH starts listing medicines.

2.5. Fast track registration of medicines for diseases of public interest: Products which are not prequalified by WHO, registered in SRA countries, recommended for registration by ZAZIBONA or AMRH can be registered through this fast tract registration procedure. Full expedited review process is done by PMRA. Only products from manufacturing plants with cGMP issued by PMRA are eligible for this fast track pathway. Regulatory registration period is 180 days.

Registration Procedure under ZAZIBONA:

Registration procedure for Medicines recommended for registration by ZAZIBONA is available for download below:

Registration procedure for medicines recommended for registration by ZAZIBONADownload