GUIDELINES

RESOURCES Guidelines Drug and Nutraceuticals Safety Monitoring Clinical Trials Herbal & Homeopathic Medicines Medical Devices, Cosmetics & Household Chemicals Registration Tobacco & Substances Of Abuse Food Products Manufacturing Products Veterinary Products Guidelines wdt_ID wdt_created_by wdt_created_at wdt_last_edited_by wdt_last_edited_at S/N Guideline Name Category Sub Categorgy 1 Kelvin 17/01/2025 06:39 AM Kelvin 17/01/2025 06:42 AM 1 Guideline on Variations Drug and Nutracetical Products Allopathic Products 2 Kelvin 17/01/2025 06:39 AM Kelvin 17/01/2025 06:55 AM 2 FDA Reliance Guideline on Regulatory Decision Making Drug and Nutracetical Products Allopathic Products 3 Kelvin 17/01/2025 06:39 AM Kelvin 17/01/2025 06:56 AM 3 Guideline on Donation of Drugs Drug and Nutracetical Products Allopathic Products 4 Kelvin 17/01/2025 06:39 AM prmis 20/01/2025 10:18 AM 4 Guideline on Conducting Bioequivalence Studies Drug and Nutracetical Products Allopathic Products 5 Kelvin 17/01/2025 06:39 AM prmis 20/01/2025 10:21 AM 5 Guidelines on Parallel Importation of Medicinal Products Drug and Nutracetical Products Allopathic Products 6 Kelvin 17/01/2025 06:39 AM prmis 20/01/2025 10:22 AM 6 Guidelines on Registration of Allopathic Drugs Drug and Nutracetical Products Allopathic Products 7 Kelvin 17/01/2025 06:39 AM prmis 20/01/2025 10:23 AM 7 Guidelines on Registration of Allopathic Drugs - Quality Drug and Nutracetical Products Allopathic Products 8 Kelvin 17/01/2025 06:39 AM prmis 20/01/2025 10:25 AM 8 Guidelines on Emergency Use Authorization of Medical Products Drug and Nutracetical Products Allopathic Products 9 Kelvin 17/01/2025 06:39 AM prmis 20/01/2025 10:26 AM 9 Guideline on FDA Public Assessment Report Drug and Nutracetical Products Allopathic Products 10 Kelvin 17/01/2025 06:39 AM prmis 20/01/2025 10:27 AM 10 Guideline on Labelling of Drugs Drug and Nutracetical Products Allopathic Products table.wpDataTable { table-layout: fixed !important; } table.wpDataTable td.numdata { text-align: right !important; } Content current as of:04/11/2025 Drug and Nutraceticals Products Guidelines for the Registration of Allopathic Products Guideline on Variations FDA Reliance Guideline on Regulatory Decision Making Guideline on Donation of Drugs Guideline on Conducting Bioequivalence Studies Guidelines on Parallel Importation of Medicinal Products Guidelines on Registration of Allopathic Drugs Guidelines on Registration of Allopathic Drugs-Quality Guidelines on Emergency Use Authorization of Medical Products Guideline on FDA Public Assessment Report Guideline on Labelling of Drugs Guidelines on Naming of Medicinal Products Guidelines on Registration of Orphan Drugs Guideline on Registration of Allopathic Medicines Considered for Small Scale Manufacture Guidelines on Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products Guideline on Registration of UK Generics Guideline for Importation of Drugs Guideline on the Registration of Medicinal Products Classified for Fast Track Processing Guideline on the Withdrawal, Cancellation or Suspension of Marketing Authorization of Drugs Process Flow and Timelines for Medicinal Product (Fast Tack) Registration(1) Process Flow and Timelines for Medicinal Product Variation Process Flow and Timelines for Medicinal Product Registration Process Flow and Timelines for Medicinal Product Re-Registration Safety Monitoring Guidelines for Adverse Reaction Reporting Guidelines for Adverse Reaction Reporting Clinical Trials Guidelines for Clinical Trials Guideline for Conduct of Clinical Trial During Emergencies Guideline for Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines and Medical Devices in Ghana Guidelines for Conduct of Clinical Trials with Paediatric Population Guidelines on Good Clinical Practice in Ghana Guidelines on the Content and Procedure for Development and Publication of Public Assessment Reports for Clinical Trial Applications Guidelines for Facility Licence Guidelines/ Codes of Practices for Slaughter House/ Slabs, Transportation of Meat, Meat Markets or Shops, Meat Processing & Cold Storage Facilities Guideline for Conducting cGMP Inspection on Herbal Manufacturing Facilities Located in Ghana Guideline for Licensing of Food Manufacturing Facility Guideline for the Establishment of a Food Processing Plant Waiver for cGMP Inspections of Pharmaceutucal Products, Innovator Vaccines & Biological Product Manufacturers Guideline for Licensing of Premises for Manufacturing Cosmetics & Household Chemical Substances Guidelines for the Registration of Food/ Nutrition/ Dietary Supplements Guidelines for the Registration of Food/ Nutrition/ Dietary Supplements Guideline on Registration of Veterinary Nutritional Dietary Supplement Guidelines for the Veterinary Product Registration Guideline on Registration of Veterinary Medicinal Product Product Literature Standard for Veterinary Products Herbal & Homeopathic Medicines Guidelines for the Herbal & Homeopathic Product Guidelines for Registration of Herbal Medicine FDA Reliance Guideline on Regulatory Decision Making Medical Devices, Cosmetics & Household Chemicals Registration Cosmetics & Household Chemicals Guideline for Parallel Importation of Cosmetics & Household Chemicals Guideline for Registration of Cosmetics & Household Chemicals Guideline for Labelling Requirements Registration Requirements for Imported Cosmetic Product Registration Requirements for Local Cosmetic Products Medical Devices Registration Guideline for Donation of Medical Devices Guideline for Importation of Medical Devices Guideline for Naming of Medical Devices Guideline for Registration of Software as Medical Device Guideline for Used & Refurbished Medical Equipment Guidelines for Disposal of Unwholesome Product Guidelines for Product Recall Guidelines for Registration of Homemade Face Masks Guidelines for the Registration of Medical Devices Tobacco & Substances Of Abuse Guidelines For The Registration Of Tobacco & Substances Of Abuse A Guide for Managers on the Prohibition of Smoking in Public Areas Guidelines for Importation of Controlled Substances Guidelines for Sales, Supply and Use of Controlled Substances Guidelines for Labelling of Tobacco Products Guidelines for the Registration of Tobacco & Tobacco Products Specifications for Designated Smoking Areas Specifications for No - Smoking Sign Food Products Imported Food Products General Labelling Requirement Guidelines For Labelling Food And Food Ingredients Derived From GMOS Guidelines For Registration As An Importer Of Food Sample Schedule Guidelines For Repackaging Of Food Products Laboratory Reporting Format Imported Parameters Labeling Requirements For Infant Formula And Follow-Up Formula Registration Requirements - Imported Food Products Sample Schedule — Official PDF notice (extracted text) — No. 17 Indian Ocean Street, Nelson Mandela Avenue, Shiashie ● Greater Accra ● Ghana P. O. Box CT 2783, Accra ● GPS: GA-237-7316 ● (+233) 302 233200 / 235100 ● fda@fda.gov.gh © FDA-GHANA, 2024. Reproduction is authorized provided the source is acknowledged FOOD AND DRUGS AUTHORITY 1 st March 2023 FDA/GEN/GDL - 04/02 CEO- FDA Governing Board FDA RELIANCE GUIDELINE ON REGULATORY DECISION-MAKING Draft written by Head, QMSD N/A Draft reviewed by Director, BDIP N/A Start of public consultation N/A Adopted by FDA Governing Board 2 nd January 2019 Final Quality Assurance Review 16 th February, 2023 Approved by CEO 20 th February 2023 Date of coming into effect 1 st March 2023 Document Revision History ______________________________________________________________________________________ Guideline on Reliance for Regulatory decision-making (FDA/GEN/GDL-04/02) Page 2 of 9 Date of Revision Version Number Changes made and/or reasons for revision 2 nd January 2019 01 Initial issue 1 st March 2023 02 General review in line with the current structure and amendment of policy to a guideline. ______________________________________________________________________________________ Guideline on Reliance for Regulatory decision-making (FDA/GEN/GDL-04/02) Page 3 of 9 Table of Contents EXECUTIVE SUMMARY .................................................................................................................... 4 1.0 INTRODUCTION ........................................................................................................................... 5 1.1 LEGAL BASIS ........................................................................................................................... 6 1.2 SCOPE ...................................................................................................................................... 6 2.0 DEFINITIONS AND ABBREVIATIONS ......................................................................................... 6 2.1 DEFINITION OF TERMS ............................................................................................................... 7 WELL-RESOURCED OR REFERENCE NATIONAL REGULATORY AUTHORITY OR ENTITY ........ 7 2.2 ABBREVIATIONS ......................................................................................................................... 8 3.0 REQUIREMENTS ......................................................................................................................... 8 3.1 TOOL FOR IMPLEMENTATION ................................................................................................... 8 3.1.1 CLINICAL TRIALS AUTHORIZATION ........................................................................................ 8 3.1.2 REGISTRATION AND/OR MARKETING AUTHORIZATION ...................................................... 9 3.1.3 REGULATORY INSPECTIONS ............................................................................................... 10 3.1.4 VIGILANCE .......................................................................................................................... 11 3.1.5 LABORATORY TESTING (QUALITY CONTROL) ............................................................... 12 4.0 ALTERNATIVE /NON-ROUTINE APPLICATION APPROVAL PATHWAYS .............................. 12 5.0 RELIANCE PROCEDURE .......................................................................................................... 12 5.3 DOCUMENTATION ..................................................................................................................... 14 5.4 EVALUATION .............................................................................................................................. 14 6.0 CLINICAL TRIALS AUTHORIZATION ........................................................................................ 15 7.0 MARKETING AUTHORIZATION PATHWAY ............................................................................. 16 8.0 REFERENCES ............................................................................................................................ 17 ______________________________________________________________________________________ Guideline on Reliance for Regulatory decision-making (FDA/GEN/GDL-04/02) Page 4 of 9 Executive Summary This guideline is intended to assist applicants appreciate the FDA’s regulatory reliance pathway which seeks to bring greater efficiency to the regulatory process by eliminating duplicative work, strengthening regulatory systems, promoting harmonization and optimizing resource utilization with a focus on value-added activities without sacrificing product quality, safety, or efficacy. ______________________________________________________________________________________ Guideline on Reliance for Regulatory decision-making (FDA/GEN/GDL-04/02) Page 5 of 9 1.0 Introduction To promote a more efficient approach to regulation, thereby improving access to quality-assured, effective and safe medical products, the FDA has developed and implemented alternative /non-routine authorization application pathways to the standard/routine approval pathways, especially for applications where the safety and efficacy of the product have already been confirmed or when the Clinical Trial has been approved and/or initiated (partly or wholly – phase I/II/III) in a well – resourced setting and by well-resourced National Regulatory Authorities (NRAs). The instituted alternative pathways are designed to facilitate regulatory reviews and evaluations in a timely manner and at the same time, accelerate the evaluation process without compromising the quality of work conducted on submitted documents while ensuring that authorized products or clinical trials meet established and published regulatory requirements, which are internationally accepted. Further, it focuses on risk-based evaluations, concentrating on what is locally critical (i.e. value-added in terms of resource/time investment) versus what can be leveraged/relied upon from decisions made by a well-resourced NRAs that operates within the ICH region and other reference countries, Regional Economic Communities (RECs). The aim is to expedite the entire application submission and evaluation process towards timely regulatory decision-making. The activity is achieved in a variety of ways, including information and/or work-sharing and reliance (partly or fully) on assessment reports generated by well-resourced NRAs, GMP/GCP inspection reports, QC laboratory reports and similar documents. The FDA’s perception of reliance implies that the work done is shared by the well- resourced NRA (e.g. through assessment reports, inspection reports, QC lab reports, etc...), while the FDA uses this work according to its own scientific knowledge and regulatory procedures (such as differences in conditions of use, patient population, ______________________________________________________________________________________ Guideline on Reliance for Regulatory decision-making (FDA/GEN/GDL-04/02) Page 6 of 9 etc...) and retains its own regulatory responsibilities. The FDA accepts that reliance can be unilateral, bilateral (mutual) or multilateral and it will leverage the information in the imported reports and/or decisions to arrive at a regulatory decision but will maintain its own regulatory responsibilities for decision-making. Note: The FDA shall activate the reliance pathway to facilitate regulatory decisions either on a case-by-case basis or at the explicit request of the Applicant. The objective of this guideline is to expedite the evaluation and decision-making process of applications submitted, which have been approved by a well-resourced NRA while retaining the FDA’s regulatory responsibilities and decision-making. The FDA will consider and give significant weight to assessment reports prepared by a well-resourced NRA or trusted institution or REC or to any other authoritative information in reaching its own decision. This guideline will provide high level requirements spanning the full life cycle of a medical product. 1.1 Legal Basis Section 148 Public Health Act, 2012, Act 851 gives the Food and Drugs Authority the mandate to issue guidelines and codes of practice in connection with the regulation of food and drugs and any other products or devices regulated by the Authority. 1.2 Scope This guideline shall be applicable to marketing authorization of human and veterinary allopathic drugs, vaccines and other biological products and medical devices, authorization of all phases of Clinical Trials, Good Manufacturing Practice inspection, Quality Control testing, vigilance, lot release, market surveillance and control and licensing establishment. 2.0 DEFINITIONS AND ABBREVIATIONS ______________________________________________________________________________________ Guideline on Reliance for Regulatory decision-making (FDA/GEN/GDL-04/02) Page 7 of 9 2.1 DEFINITION OF TERMS Well-resourced or reference National Regulatory Authority or Entity A well-resourced or reference national regulatory authority is: I. a member of ICH prior to 23 October 2015, namely: the US Food and Drug Administration, the European Commission and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency; or II. an ICH observer prior to 23 October 2015, namely: the European Free Trade Association, as represented by Swissmedic and Health Canada; or III. a regulatory authority associated with an ICH member through a legally binding, mutual recognition agreement prior to 23 October 2015, namely: Australia, Iceland, Liechtenstein, and Norway. IV. ICH regulatory member such as HAS, Singapore; MHRA United Kingdom; MFDS, Republic of Korea. V. A regulatory authority designated by the WHO through the WHO GBT as a Maturity Level 3 or 4 NRA or a WHO Listed Authority. VI. An entity formed by a regional body or global body dedicated to expanding universal health coverage, as well as directing and coordinating the regional or global response to health issues and/or emergencies and promoting healthier lives (e.g., WAHO, WHO, etc.) ______________________________________________________________________________________ Guideline on Reliance for Regulatory decision-making (FDA/GEN/GDL-04/02) Page 8 of 9 2.2 ABBREVIATIONS AMA African Medicines Agency AVAREF African Vaccine Regulatory Forum API Active Pharmaceutical Ingredient CT Clinical Trials EC European Commission EMA European Medicines Agency GCP Good Clinical Practice GMP Good Manufacturing Practice HPTD Health Products and Technologies Division ICH International Council on Harmonization ILAC International Laboratory Accreditation MHLW Ministry of Health, Labour and Welfare Japan MAH Marketing Authorization Holder NRA National Regulatory Agency PAR Public Assessment Report PMDA Pharmaceutical and Medical Devices Agency PQ Prequalification QC Quality Control TGA Therapeutic Goods Administration US FDA United States Food and Drug Administration WHO World Health Organization 3.0 Requirements 3.1 Tool for implementation The following tools shall be used to ensure full implementation and compliance to the reliance route: 3.1.1 Clinical Trials Authorization 1. If the product under investigation has already been evaluated and listed as a WHO ______________________________________________________________________________________ Guideline on Reliance for Regulatory decision-making (FDA/GEN/GDL-04/02) Page 9 of 18 Prequalified Product through the WHO PQ collaborative registration procedure between WHO and NRAs 2. If the product under investigation has already been evaluated and listed as a product of either the WHO collaborative registration pilot for stringently authorized products, including through the EU’s Article 58 Procedure or the Swiss medic’s Marketing Authorization for Global Health products or the International Generic Drug Regulatory Program (launched July 2014). 3. If either the trial or the investigational product has been authorized or granted marketing authorization in either an ICH founding regulatory member state or region (such as EC (EMA), United States (United States Food and Drugs Administration), Japan (MHLW/PMDA) or an ICH standing regulatory member state or region (such as Canada (Health Canada), Switzerland (Swissmedic). Further, products registered by TGA of Australia, Iceland, Liechtenstein, MHRA of UK and Norway shall be considered through the reliance route. 4. If the product under investigation has already been evaluated and approved for use by a WHO GBT Maturity Level 3 or 4 NRA or a WHO Listed Authority (WLA). 5. If either the trial or the investigational product has been evaluated and judged satisfactory at a joint review meeting facilitated by the World Health Organization under the African Vaccine Regulatory Forum (AVAREF). 3.1.2 Registration and/or Marketing Authorization 1. The product should have been evaluated and listed as a WHO Prequalified product through the WHO PQ collaborative registration procedure between WHO and NRAs 2. The product has already been evaluated and granted MA for use by a WHO GBT Maturity Level 3 or 4 NRA or a WHO Listed Authority. 3. The product should have been evaluated and listed as a product of either the WHO collaborative registration pilot for stringently authorized products, including through the EU’s Article 58 Procedure or the Swissmedic’s Marketing Authorization for ______________________________________________________________________________________ Guideline on Reliance for Regulatory decision-making (FDA/GEN/GDL-04/02) Page 10 of 18 Global Health products or the International Generic Drug Regulatory Programme (launched July 2014). The product should have been registered and/or granted marketing authorization in either an ICH founding regulatory member state or region (such as EC (EMA), United States (United States Food and Drugs Administration), Japan (MHLW/PMDA) or an ICH standing regulatory member state or region (such as Canada (Health Canada), Switzerland (Swissmedic). Further, products registered by TGA of Australia, Iceland, Liechtenstein, MHRA of UK and Norway shall be considered through the reliance route. 4. The product should have been evaluated and listed as an output of the West African Medicines Harmonization initiative of the Economic Community of West African States (ECOWAS). 3.1.3 Regulatory Inspections 2. The product should have been evaluated and listed as a WHO Prequalified Product through the WHO PQ collaborative registration procedure between WHO and NRAs, and the manufacturing facility should have been inspected by the NRA in the country of origin and the WHO pre-qualification team. 3. The manufacturing facility of the product of interest should have been inspected by an NRA designated by the WHO via WHO GBT as a Maturity Level 3 or 4 NRA or as a WHO listed Authority. 4. The product should have been evaluated and listed as a product of either the WHO collaborative registration pilot for stringently authorized products, including through the EU’s Article 58 Procedure or the Swissmedic’s Marketing Authorization for Global Health products or the International Generic Drug Regulatory Programme (launched July 2014), and the manufacturing facility should have been inspected by the NRA in the country of origin and/or the WHO pre-qualification team. 5. The product should have been registered and/or granted marketing authorization in either an ICH founding regulatory member state or region (such as EU (EMA), United States (United States Food and Drugs Administration), Japan ______________________________________________________________________________________ Guideline on Reliance for Regulatory decision-making (FDA/GEN/GDL-04/02) Page 11 of 18 (MHLW/PMDA) or an ICH standing regulatory member state or region (such as Canada (Health Canada), Switzerland (Swissmedic). Further, a product registered by TGA of Australia, Icel