UK MHRA Specifies Eligibility For Consultancy Firms To Monitor GMP, GDP Compliance
Consultancy firms must have at least five years of experience in carrying out independent GMP or GDP audits if they want to apply to become a “compliance monitor” under a new MHRA scheme to keep track of drug companies that fail to comply with GMP/GDP requirements.
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The MHRA is testing the feasibility of appointing eligible external consultants to be its eyes and ears when it comes to checking up on drug companies that have failed to meet good manufacturing and distribution practice requirements.
A technical workshop is planned for later this year to identify common “use cases” for real-world evidence that are important to the European Medicines Agency, health technology assessment bodies and payers.
The EU’s conditional approval of four COVID-19 vaccines and its decision to extend the use of Pfizer/BioNTech’s Comirnaty to a younger age group were challenged in the court last year but the cases were declared inadmissible.