The EU has developed a regulatory system based on a network of decentralized National Competent Authorities (NCAs) in the Member States, supported and coordinated by a centralized agency, the European Medicines Agency (EMA).
The European Commission’s role is multifaceted and focuses on the following:
- Right of initiative: To propose new or amending legislation for the pharmaceutical sector
- Implementation: To adopt implementing measures as well as to ensure and monitor the correct application of EU law
- Risk management: To grant EU-wide marketing authorizations for centralized products or maximum residue limits on the basis of a scientific opinion of the EMA
- Supervisory authority: To oversee the activities of the EMA in compliance with the mandate of the EMA, EU law and the EU policy objectives
- Global outreach: To ensure appropriate collaboration with relevant international partners and to promote the EU system globally
The EMA was created in 1995 to coordinate the existing scientific resources in the EU Member States and is an interface for cooperation and coordination of Member States’ activities with respect to medicinal products. EMA scientific decisions are made through its scientific committees, whose members are chosen on the bases of their scientific expertise and are appointed by the Member States. One of the main roles of EMA is to mobilize scientific resources in the Member States, so that many of its scientific activities are carried out through a large network of scientific experts made available by the Member States.
The system for Marketing Authorisation (MA) of medicines, including the referral procedure, is an example of how the European Commission, the EMA and the Member States cooperate. The EU national, decentralized and mutual recognition MA procedures coexist with the centralized procedure (Table 1).
The referral procedure is an EU binding mechanism that ensures that the same measures are applied to products subject to national, decentralized and mutual recognition MA procedures. This procedure may be notably invoked when the conditions of authorizations need to be reviewed in the light of quality, safety and efficacy data (Union Interest Referral), when Member States have adopted different decisions regarding products that are authorized in at least two Member States (Divergent Decision Referral) or in the absence of agreement among Member States in the course of the mutual recognition or decentralized authorization procedures (Mutual Recognition and Decentralised Referral). This mechanism involves an opinion from the appropriate EMA committee and results in a decision of the European Commission that is binding for all Member States.
In order to provide for the same level of access to critical medicines to all the patients in the Union, the centralized procedure is mandatory for orphan products, biotechnological products, advanced-therapy products (gene therapy, somatic cell therapy and tissue engineering) and products intended for the treatment of critical therapeutic classes (HIV or AIDS, cancer, diabetes neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases). Veterinary medicines for use as growth or yield enhancers are also in the mandatory scope of the centralized procedure.
A fundamental aspect is that the legislation applicable to pharmaceuticals in the European Union is the same irrespective of the Member State or authorization route of the product, as it is developed at Union level. The same applies to the guidelines in use by assessors and inspectors for the assessment of MA applications and inspections, which are developed by EMA, in cooperation with Member States, through its scientific committees and working groups.
Clinical trials of Investigational Medicinal Products (IMPs) require authorization by each NCA and a favorable opinion by an ethics committee in which the clinical trial takes place and is granted in the form of a Clinical Trial Authorisation (CTA). The assessment for a CTA takes into account the holding of an appropriate authorization for each EU site of manufacture or importation.
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See: https://manoxblog.com/2023/01/14/fda-warning-letters-2018-to-2023/
