How can an EU-GMP certified facility register a drug in Europe?

After getting an EU-GMP certification, facilities must face other challenges: register a drug in Europe, Drug registration in the EU is a complex process that requires strict adherence to the regulations of the European Medicines Agency (EMA) or the corresponding national regulatory authorities.

Referencing the EMA’s Marketing Authorization guidelines, here are the basic steps for drug registration in the EU:

1. Preparation of necessary documents and data:

Preclinical data: Includes laboratory and animal studies to determine the drug’s safety and efficacy.
Clinical data: Human clinical trials to demonstrate the drug’s efficacy and safety..
CMC (Chemistry, Manufacturing and Controls) data: Detailed information about the drug’s composition, manufacturing process, and quality control.

2. Choosing a procedure for drug registration in the EU:

There are four main procedures for drug registration in the EU following EU-GMP standards:

2.1. Centralized Procedure – CP

EMA acts as the regulatory authority for the centralized procedure. The application is submitted directly to EMA, and the product is granted a single marketing authorization (MA). A Committee for Medicinal Products for Human Use (CHMP), with representatives from each EU member state, evaluates the application.

Within 7 months of evaluation, if approved, the product can be marketed in all EU member states. The centralized procedure is mandatory for certain products and optional for others. However, there are also products that do not qualify for the centralized procedure:

Mandatory for Centralized Procedure

– Biotechnological products

– Orphan drugs

– New active substances for treating: Diabetes, cancer, HIV, Alzheimer’s, and other autoimmune and immunodeficiency disorders

– Viral diseases

Optional for Centralized Procedure

– New active substances

– Innovative medicinal products

– In the interest of public health at the Community level

Epidemics
Generic medicines authorized nationally
OTC medicines

– Generic medicines authorized via CP

2.2. Mutual Recognition Procedure – MRP

Applies to drugs already approved in one EU member state. The Marketing Authorization Holder (MAH) wants to obtain a Marketing Authorization (MA) for the same product in at least one other Member State. An application is submitted to recognize this authorization in other member states.

2.3. Decentralized Procedure – DCP

This applies when a drug has not been approved in any EU member state. Applications are submitted simultaneously to several member states.

DCP can be used if the product has not been authorized in any member state but does not want to use the centralized procedure or the product does not qualify for centralized authorization.

Upon successful application, each Member State grants an MA and allows the product to be marketed in their respective countries.

2.4. National Procedure – NP

Applies when registering a drug in a single member state, and the product can only be sold in that specific EU country. The application must be submitted to the competent authority of one Member State.

The national procedure is applied to products outside the scope of the EMA’s centralized procedure. The product must be submitted along with the Summary of Product Characteristics (SPC) as a basis for marketing the product.

The marketing authorization (MA) is valid for 5 years and after the first renewal, the MA is valid for an unlimited period.

Procedures for drug registration in the EU:

Registration procedures	Centralized Procedure – CP	Mutual Recognition Procedure – MRP	Decentralized Procedure – DCP	National Procedure – NP
Application	Mandatory for some products: new drug, improved drug; drugs for treating cancer, HIV/AIDS, rare diseases, and some others	The product has been approved at a RMS	The product has never been approved by any EU member state.	Register a drug in a single member state. Apply to products outside the scope of the EMA’s centralized procedure.
Submit	Directly to EMA	An application is submitted to recognize the authorization in other member states.	Applications are submitted simultaneously to several member states.	The application must be submitted to the competent authority of one Member State.
Approve	– 1 scientific evaluation from EMA. – if approved, the product can be granted MA in all EU member states	CMS will recognize and approve MA based on the initial evaluation.	– RMS performs the evaluation. – CMS may reject. – RMS and CMS grant the MA	The MA is valid in one specific EU country
Advantages	Relatively fast and approved by all member states.	Need to submit only 1 application	Get approved by many member states	If the application is rejected by 1 member state, still can approach the other ones
* RMS: Reference Member State ; CMS: Concerned Member State Feeling lost and unsure where to start? SEN Pharma’s EU-GMP consultancy services can guide you every step of the way. Contact us on Zalo (086 918 0917) for personalized advice and support.