Application Processes

Last Updated on January 20, 2023

The applications for registration or marketing authorization of pharmaceutical and biological drug products are reviewed and evaluated by the Division of Pharmaceutical Evaluation and Registration (PE&R) and Division of Biological Drugs (BE&R) respectively. Evaluation summaries are presented before the Registration Board of DRAP. The Evaluation process flows and process descriptions for various types of drugs and biologicals are provided below:

Pharmaceutical Drugs

Registration of Pharmaceutical Drug for Human Use on Form 5-F:-

Application for registration of Pharmaceutical drug shall be submitted by the manufacturer / importer on Form-5F (CTD format) with supporting documents and applicable fee. The evaluation process flow and process description are being provided for illustrative purpose.

Registration of Pharmaceutical Drug for Veterinary Use (Other than Form 5-F):-

Application for registration of Pharmaceutical drug for veterinary use shall be submitted by the manufacturer / importer on relevant application form (Form 5/5A/5D/5E) along with requisite documents and applicable fee. The evaluation process flow and process description is provided for illustrative purpose.

Registration of Pharmaceutical Drug for Export:-

Application for registration of Pharmaceutical drug for export purpose shall be submitted by the manufacturer / importer on Form-5/ 5D with supporting documents and applicable fee. The evaluation process flow and process description is provided for illustration.

Post Registration Variation of Pharmaceutical Drug:-

Application for any post registration variation of Registered Pharmaceutical drugs shall be submitted by the manufacturer / importer with supporting documents and applicable fee. The evaluation process flow and process description is provided for illustration.

Renewal of Registration of Pharmaceutical Drug:-

Applications for renewal of registration of Pharmaceutical drug shall be submitted by the manufacturer / importer on Form-5B along with supporting documents and applicable fee. The evaluation process flow and process description is provided for better illustration.

Biological Drugs

Registration of Biological Drug for Human Use:-

Application for registration of biological drug for human use shall be submitted on Form 5F along with requisite documents and fee challan. The evaluation process flow and process description are being provided for illustrative purpose.

Registration of Biological Drug for Veterinary Use:-

Application for registration of biological drug for veterinary use shall be submitted on relevant application form (5/5A/5D/5E) along with requisite documents and fee challan. The evaluation process flow and process description are being provided for illustrative purpose.

Registration of Biological Drug for Export:-

Application for registration of biological drug for export purpose shall be submitted on relevant application form (5/5A/5D) along with necessary documents and fee challan. The evaluation process flow and process description are being provided for illustrative purpose.

Post Registration Variation of Biological Drug:-

Application for any post registration variation of registered biological drug shall be submitted with requisite documents and fee. The evaluation process flow and process description are being provided for illustrative purpose.

Renewal of Registration of Biological Drug:-

Application for renewal of registration of biological drug shall be submitted on Form-5B along with supporting documents and applicable fee. The evaluation process flow and process description are being provided for illustrative purpose.