Together with the partnering African national medicines regulatory authorities (NMRAs) in the three GHPP projects; RegTrain-PharmTrain, PharmTrain-CoronaGlobal and PharmTrain2 (Structure Development), developed harmonised regulatory guidelines and a regional framework in close collaboration with the PharmTrain team of the BfArM.

NMRAs are invited to use the documents in this database for their structural strengthening, provided the authors are credited.

PharmTrain2 project (2023-today)

• Guideline on Impurities in new Active Pharmaceutical Ingredients
• Guideline on Impurities in new Finished Pharmaceutical Products
• Guideline on In-Use Stability Testing of Human Medicinal Products
• Guideline on Pharmaceutical Development
• Guideline on Photostability Testing
• Guideline on Specifications

PharmTrain-CoronaGlobal project (2020-2023)

Framework for Emergency Use Authorisation | For the National Medicines Regulatory Authorities of the Southern African Development Community | SADC-EUA-F

RegTrain-PharmTrain project (2019-2022)

• Guideline on Guidelines
• Definitions list
• Guideline on Bioanalytical Method Validation
• Guideline on Bioequivalence
• Guideline on Donation
• Guideline on Emergency Use Authorization
• Guideline on Reliance
• Guideline on Renewal
• Guideline on Stability Testing
• Guideline on Withdrawal, Suspension, Revocation or Cancellation of Marketing Authorization