Drugs are approved in England by the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA is the UK government agency responsible for ensuring the safety, quality, and effectiveness of medicines, medical devices, and blood components for transfusion. Their work encompasses a wide range of activities, from licensing new medicines to monitoring their safety once they are on the market. Here's a breakdown of the drug approval process:
MHRA Review Process
The MHRA rigorously reviews all new drugs submitted for approval. This process involves assessing several key aspects:
- Safety: The MHRA evaluates the potential risks and side effects associated with the drug, comparing them to the potential benefits. Clinical trial data is scrutinized to identify any safety concerns.
- Quality: The MHRA ensures that the drug is manufactured to a high standard and that it consistently meets pre-defined quality specifications. This includes evaluating the manufacturing processes, quality control measures, and the stability of the drug product.
- Efficacy: The MHRA examines clinical trial data to determine whether the drug is effective in treating the intended condition. This assessment involves evaluating the drug's ability to produce a clinically meaningful benefit for patients.
Key Responsibilities of the MHRA
The MHRA's role extends beyond just reviewing new drugs. They also have ongoing responsibilities, including:
- Monitoring the safety of medicines: Once a drug is approved and available on the market, the MHRA continues to monitor its safety through a variety of mechanisms, including adverse event reporting and post-market surveillance studies.
- Ensuring the safety of the supply chain: The MHRA works to ensure that the supply chain for medicines is secure and that counterfeit or substandard drugs do not enter the market.
- Setting and enforcing standards: The MHRA sets and enforces standards for the quality, safety, and efficacy of medicines, medical devices, and blood components.
Brexit Implications
Following Brexit, the MHRA became the sole authority responsible for approving drugs for the UK market. Previously, the European Medicines Agency (EMA) played a significant role in approving drugs for use in the UK. This means the MHRA is now fully responsible for setting its own regulatory standards and making its own decisions about which drugs should be available to patients in England (and the rest of the UK).
In summary, drug approval in England is a rigorous process overseen by the MHRA, ensuring that only safe, effective, and high-quality medicines are made available to patients.
