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UK MHRA Guidance: Medicines – Apply for a Variation to Your Marketing Authorisation
Marketing Authorisations (MAs) require updates throughout a medicine's lifecycle to reflect changes in manufacturing, quality, safety, efficacy, product information, or administrative details. To ensure that these changes are appropriately assessed and approved while maintaining product quality and patient safety, the Medicines and Healthcare products Regulatory Agency (MHRA) provides detailed guidance on applying for variations to UK Marketing Authorisations. The MHRA guidan
Sharan Murugan
1 day ago4 min read
Pakistan's DRAP: Guidelines for Post-Registration Variation of Drugs
Earlier today (04 July, 2023), the Drug Regulatory Authority of Pakistan released an updated draft guidance on "Guidelines for...
Sharan Murugan
Jul 4, 20231 min read
SAPHRA (ECTD & Human Medicines Unit): Variation Communication Guideline
South African Health Products Regulatory Authority (SAHPRA) on 30 September 2022, released updated guidance on " Business As Usual (BAU)...
Sharan Murugan
Oct 3, 20221 min read
Saudi Arabia’s (SFDA) Guide on Regulatory Framework for Drug Registration, Variation or Renewals
Saudi Arabia’s (SFDA) updated Guide on Regulatory Framework for Drug Registration, Variation or Renewal The Drug Sector in Saudi Food &...
Sharan Murugan
Oct 19, 20211 min read