What are CHMP guidelines?
What is a CHMP? A CHMP is an agreement between a land user (sponsor) and Traditional Owners (endorsed party) developed under Part 7 of the Cultural Heritage Acts. The CHMP explains how land use activities can be managed to avoid or minimise harm to Aboriginal or Torres Strait Islander cultural heritage.
What is a CHMP opinion?
The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union. The Commission usually makes a decision about whether to approve a new drug candidate within two to three months of CHMP issuing its recommendation.
Is CHMP part of EMA?
The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency’s committee responsible for elaborating the agency’s opinions on all issues regarding medicinal products for human use.
What are the EMA guidelines?
EMA scientific guidelines are EU Community documents that are intended to provide advice to companies applying for market authorization and competent authorities in member states.
What is CHMP in pharma?
Committee for Medicinal Products for Human Use: the committee that is responsible for preparing the Agency’s opinions on questions concerning human medicines. More information can be found under ‘Committee for Medicinal Products for Human Use (CHMP)’.
What does CHMP stand for EMA?
Committee for Medicinal Products for Human Use
The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency’s (EMA) committee responsible for human medicines.
What does CHMP stand for?
CHMP
| Acronym | Definition |
|---|---|
| CHMP | Committee for Medicinal Products for Human Use |
| CHMP | Cultural Heritage Management Plan |
| CHMP | Committee on Human Medicinal Products (European Medicines Agency) |
| CHMP | Centrale Humanitaire Médico-Pharmaceutique |
What is mutual recognition procedure?
The mutual recognition procedure is to be used in order to obtain marketing authorisations in several Member States where the medicinal product in question has received a marketing authorisation in any Member State at the time of application.
What is the responsibility of the Committee for Medicinal Products CHMP for human use?
The Committee for Medicinal Products for Human Use ( CHMP ) is responsible for the scientific evaluation of the application dossier on the quality, efficacy and safety (including environmental safety) of the medicinal product as part of the centralized marketing authorization procedure for new medicinal products.