EMA-CHMP

The Committee for Medicinal Products for Human Use (CHMP)

The Committee for Medicinal Products for Human Use (CHMP) is a key committee within the European Medicines Agency (EMA). It is responsible for preparing the EMA’s opinions on all questions concerning human medicines.

The CHMP plays a crucial role in the authorization of medicines in the European Union (EU) through the following activities:

• Initial Assessment: Conducting the initial scientific assessment of EU-wide marketing authorization applications for new medicines.
• Variations and Extensions: Evaluating modifications or extensions to existing marketing authorizations.
• Safety Monitoring: Considering recommendations from the Pharmacovigilance Risk Assessment Committee (PRAC) on the safety of medicines and recommending changes, suspensions, or withdrawals of marketing authorizations when necessary.
• Referral Procedures: Evaluating medicines authorized at the national level that are referred to the EMA for a harmonized position across the EU.
• Scientific Advice and Guidelines: Providing scientific advice to companies developing new medicines and preparing scientific guidelines to help with marketing authorization applications.

The CHMP contributes to the validation of New Approach Methodologies (NAMs) in several ways:

• Scientific Evaluation: The CHMP conducts rigorous scientific evaluations of data submitted by pharmaceutical companies, ensuring that NAMs meet the necessary quality, safety, and efficacy requirements.
• Guideline Development: The committee prepares scientific guidelines and regulatory guidance to help companies develop and validate NAMs, ensuring they are robust and reliable.
• International Collaboration: The CHMP works with international partners to harmonize regulatory requirements, facilitating the global acceptance and validation of NAMs.
• Peer Review: An internal peer-review system within the CHMP safeguards the accuracy and validity of its opinions, ensuring that NAMs are thoroughly vetted before being recommended for use.

For additional support or helpdesk information, you can reach out to the CHMP directly through the EMA contact page. They offer resources and support for questions about the evaluation and authorization of medicines.