Processing and granting marketing authorization for allopathic medicines (human and veterinary) and nutraceuticals intended for export and/or sale on the Ghanaian market.

This process includes;

1. Processing approvals for new, renewal, and variation applications

2. Coordinating dossier evaluation and product registration meetings

3. Maintaining the Drug Register

4. Correspondence with applicants

5. Issuance of registration certificates

6. Revocation of registration certificates

7. Drafting and reviewing of guidelines and codes of practice

8. Stakeholder’s engagement on matters relating to registration of pharmaceutical products

9. RCORE on Medicines Evaluation and Registration

10. Vetting of brand names for Allopathic and Veterinary drugs

11. Processing of Permits for Importation of Raw materials and Personalized Prescription

Timelines for Processing New and Renewal Applications

· High Risk and Low Risk Applications – 12 months (360 days)

· Fast Track Applications – 6 months (180 days)

· Reliance Applications – 3 months (90 days)

· Renewal Applications – 3 months (90 days)

Timelines for Processing Variation Applications

· Notifications (Do and Tell)

· Immediate notification -1-month

· annual notification -12 months

· Minor Variations (Do, Tell, and Wait) – 3 months.

· Major Variations (Requires formal approval) – 6 months Fresh Applications

Regional Center of Regulatory Excellence (RCORE) for Medicine Evaluation Registration in Africa

FDA Ghana was designated by the New Partnership for African Development (NEPAD) and the African Regulatory Harmonization (AMRH) as a Regional Centre of Regulatory Excellence (RCORE) in Drug Registration in May 2014.

As an RCORE, the FDA in collaboration with the School of Public Health, University of Ghana, seeks to build capacity in dossier assessment within the sub-region and improve access to medicines through harmonization of regulatory requirements. This will ensure quality, safe and efficacious medicines are available to African citizens.