Overview of SFDA Regulatory Timelines for Pharmaceuticals and Medical Devices

Veterinary Biologics not registered in SRA 385 243 Herbal & health products 155 Drugs go through 30 working days verification or 60 working days abridged pathway review. Application must be submitted within two years from date of approval by reference agency Verification Registration : it is a process where the product has been approved and marketed by both of the following drug regulatory agencies. For human medicinal products: EMA and FDA. For veterinary medicinal products: EMA and FDA (for new veterinary products), USDA (for biological veterinary products). Abridged Registration : it is a process where the product has been approved and marketed by either of the following drug regulatory agencies. For human medicinal products: EMA or FDA. For veterinary medicinal products: EMA or FDA (for new veterinary products), USDA (for biological veterinary products).

The applicant will have a maximum of four (4) waves for Assessment and pricing,

and the SFDA has the right to take a decision at any time during the assessment step, regardless of the wave number. The registration request will be rejected in the following cases:

No response from the applicant within 60 working days. If the applicant provided unsatisfied requirements or did not include the required documents or justification for the absence of a document according to SFDA guidelines

V a r iation Type Timeline IA – Such minor variations do not require prior approval before implementation 30 IB – Such minor variations must be submitted to the authority by the Marketing Authorization Holder (MAH) before implementation, but do not require formal approval. 60 II – Such major variations, which may have a significant impact on the Quality, Safety or Efficacy of a medicinal product and require prior approval before implementation. 100

Appeal Type Timeline F i r s t Appeal – After Business Validation 30 Second Appeal- After Evaluation & Inspection 60 Price Appeal 60

Type Timeline MDMA Registration 35 MDMA Update – Minor 15 MDMA Update – Major 35