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South Africa SAHPRA Guideline on Post-Marketing Reporting of Adverse Drug Reactions
The South African Health Products Regulatory Authority (SAHPRA) has issued the Guideline on Post-Marketing Reporting of Adverse Drug Reactions (ADRs) to Human Medicine to guide Applicants and Holders of Certificates of Registration (HCRs) on the collection, management and reporting of safety information after registration. The guideline covers ADRs, Adverse Events Following Immunisation (AEFIs) and relevant safety information associated with human medicines, including biologi
Sharan Murugan
Aug 293 min read
UK MHRA: Guidance on Send and Receive information on Adverse Drug Reactions (ADRs)
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Send and Receive information on Adverse Drug...
Sharan Murugan
May 11, 20242 min read