Guidelines

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TitleVersion (Issue) No. Date of ImplementationDocument Link
Guideline for Medicine Donation Updated
226 June 2025
Guideline for Labelling of Medicines for Human Use Updated

426 June 2025
Guideline for Marketing Authorisation (Registration) of Medicines Updated
420 January 2025
Guideline for Renewal of Marketing Authorisation
(Registration) of Medicines New
116 January 2025



Guidance for the Application in the Common Technical Document (CTD) Updated
320 January 2025
Guideline for Variations New 130 January 2025





Annex 1 of the Guideline for Variation: Administrative changes and Changes to a CEP or to a confirmation of API-prequalification document New 130 January 2025





Annex 2 of the Guideline for Variation: Quality Changes, Active Pharmaceutical Ingredient New 130 January 2025





Annex 3 of the Guideline for Variation: Quality Changes, Finished Pharmaceutical Product (FPP) or drug product New130 January 2025





Annex 4 of the Guideline for Variation: Safety and Efficacy Changes New130 January 2025





Guideline for Investigation of Bioequivalence New
120 January 2025
Guideline for Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products New
120 January 2025
Guideline for Excipients in the Dossier for Application for Marketing Authorisation of Medicines New
120 January 2025
Guideline for Impurities in New Active Pharmaceutical Ingredient New 120 January 2025
Guideline for Impurities in New Finished Pharmaceutical Products New 120 January 2025
Guideline for Withdrawal, Suspension, Revocation or Cancellation of Marketing Authorisation of Medicines New 18 April 2025
Guideline for Bioanalytical Method Validation New 18 April 2025
Guideline for Pharmaceutical Development Specifications: Test Procedures and Acceptance Criteria for new Active Pharmaceutical Ingredients and new Finished Pharmaceutical Products18 April 2025
Guideline for Specifications: Test Procedures and Acceptance Criteria for new Active Pharmaceutical Ingredients and new Finished Pharmaceutical Products New 126 June 2025
Guideline for Import and Export of Medicines and Related Products
310 July 2020
Guidance for Pre-shipment Inspection and Testing of Pharmaceutical Products Exported to The Gambia from India 115 June 2023
Guideline for Inspections by the Medicines Control Agency
201 July 2020
Guideline for Storage and Distribution of Medicines and Related Products
201 July 2020
Guideline for Recall of Medicines and Related Products
201 July 2020
Guideline for Safe Disposal of Medicines and Related Products
201 July 2020
Guideline for Advertisement of Medicines and Related Products
225 June 2020
Guideline for Licensing as Importer of Medicines and Related Products
310 July 2020
Guideline for Licensing of Facilities Storing Medicines and Related Products
110 July 2020
Guideline for Reporting of Adverse Reactions to Medicines including Vaccines Updated 302 May 2025
Guideline for Safety Monitoring of Medicines (Pharmacovigilance)
including Vaccines Updated
202 May 2025
Guideline for the National Pharmacovigilance System Updated 202 May 2025
Guidleline for Signal Management New 102 May 2025
Guideline for Clinical Trials in humans Updated

426 February 2025
Guideline for GCP Inspections of Clinical Trials New 127 June 2025
Guideline for Emergency Use Authorisation of Medi-cines including Vaccines and In-vitro Diagnostics Updated 228 January 2025
Annex 1 of the Guideline for Emergency Use Authorisation of Medicines
including Vaccines and In-vitro Diagnostics: Format of Submissions New
128 January 2025
Annex 3 of the Guideline for Emergency Use Authorisation of Medicines
including Vaccines and In-vitro Diagnostics:Details on Required Information for Submission New
128 January 2025
Annex 3a of the Guideline for Emergency Use Authorisation of Medicines
including Vaccines and In-vitro Diagnostics: Recommended Safety Data New
128 January 2025
Annex 3b of the Guideline for Emergency Use Authorisation of Medicines
including Vaccines and In-vitro Diagnostics:Recommended Effectiveness Data New
128 January 2025
Annex 3c of the Guideline for Emergency Use Authorisation of Medicines
including Vaccines and In-vitro Diagnostics: Discussion of Risks and Benefits New
128 January 2025
Annex 4 of the Guideline for Emergency Use Authorisation of Medicines
including Vaccines and In-vitro Diagnostics: Conditions of Authorisation New
128 January 2025
Guideline for Reliance on decisions, reports, or
information from other national regulatory authorities (NRAs) or regional and
international bodies Updated
226 June 2025
Annex I of the Guideline on Reliance: List of Reference
Institutions (RIs) Updated
226 June 2025
Annex II of Guideline on Reliance: Proposed
documentation for the abridged authorisation procedure
for reference institution (RI)-approved medicines Updated
226 June 2025
Guidance for Listing of Medicines and Related Products 110 October 2023