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Drug Registration Process in Europe

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Drug Registration Process in Europe

Registration process in Europe

MoH Name: European Centre for Disease Prevention and Control

MoH website: http://www.bmg.gv.at

Regulatory Authority: European Medicine Agency

Link for Regulatory Authority:  https://www.ema.europa.eu/en/homepage

Local Authorised Representative: Yes

Market Authorisation in Europe

In the European Union (EU), applications for centralized marketing authorizations must undergo a scientific examination, which is the responsibility of the European Medicines Agency (EMA). Through this authorization process, pharmaceutical firms may promote their products and make their medications available to patients and healthcare providers across the European Economic Area using a single marketing authorization that they apply to the European Medicines Agency (EMA).

In simultaneously, applicants may submit an opinion for their drug to be used outside of the EU and an EU marketing authorization under the centralized approach.

  1. Steps before submitting an application
  2. Submission of Eligibility Request:

Pharmaceutical firms frequently begin by submitting an eligibility request to the European Medicines Agency (EMA) before beginning the official application procedure. During this first stage, businesses can get crucial comments and advice on whether their product is suitable for submission.

When: 18 to 7 months before submission of marketing authorization application

  1. Notification of Intention to Submit an application:

The next step is to formally notify the EMA of your intention to submit a drug application when your eligibility has been verified. This notification streamlines the entire process by allowing the regulatory bodies to get ready for the next application.

When: 7 months before submission of marketing authorization application

  1. Appointment of Rapporteurs:

Selecting rapporteurs is an essential step in the medication registration procedure. These specialists were chosen by the EMA to assess the application that was filed. In order to provide a comprehensive and impartial assessment, rapporteurs are essential in evaluating the scientific and technical components of the dossier.

  1. Pre-Submission Meetings (Recommended):

Pharmaceutical companies can interact with regulatory bodies before submitting their application formally by holding pre-submission meetings. In these sessions, any problems may be discussed, regulatory requirements can be clarified, and the applicant and the regulatory bodies can generally align.

When: 6-7 months prior to the application for marketing authorization being submitted

  1. Re-confirmation of Communicated Submission Date:

Re-confirmation of Communicated Submission Date: It is crucial to check with regulatory bodies that the communicated submission date is still accurate when the submission deadline draws near. By doing this, it is made sure that everyone is ready and in sync for the prompt reception and processing of the medication application.

When: Two to three months prior to the marketing authorization application being submitted.

  1. Submission of Application

The formal submission of the application to the European Medicines Agency (EMA). Pharmaceutical firms put up an extensive dossier that includes specifics about preclinical and clinical research, manufacturing procedures, safety profiles, and drug development. In the process of obtaining market permission, this proposal represents a turning point. Candidates must submit their applications in the electronic common technical document (eCTD) format.

Technical validation is done by EMA on the applications it receives. The goal is to ensure that, before the procedure begins, all necessary regulatory components for scientific evaluation are included in the application. If EMA needs more information to finish validating the application, it will notify the applicant and request that it be provided by a certain date.

Fees of marketing-authorization application (single strength, one pharmaceutical form, one presentation)

Human Medicine: €345,800

Veterinary Medicine: €173,00

  1. Assessment of the application:
  2. Scientific evaluation:

The Committee for Advanced Therapies (CAT) for advanced therapy medications and the Pharmacovigilance Risk Assessment Committee (PRAC) for aspects of the risk-management plan provide feedback to the Committee for Medicinal Products for Human Use (CHMP) when it comes to the evaluation of marketing authorization applications submitted through the centralized procedure. It requires up to 210 days of activity.

The committees are made up of representatives from Iceland, Norway, and all EU member states in addition to coopted members who offer further scientific domain knowledge.

  1. CHMP scientific opinion:

Following the assessment, the CHMP publishes a scientific opinion indicating whether the medication may be approved. The European Commission receives this conclusion from EMA and grants the marketing authorization. The committee’s conclusion is then summarized by EMA and published.

  1. European Commission decision on the marketing authorization:

All centrally authorized goods are authorized by the European Commission, which bases its legally binding decision on the EMA’s recommendation.

The centralized marketing authorization, once approved by the European Commission, is recognized in all EU member states as well as Iceland, Liechtenstein, and Norway, which are members of the European Economic Area (EEA).

Decisions made by the Commission are available in the Community Registry of Human Medicinal Products. For every medication, EMA releases a European Public Assessment Report (EPAR).

EMA releases a denial EPAR, together with an assessment report and a question-and-answer document, when a new marketing authorization application is denied.

When: Within 67 days of receipt of CHMP opinion 

Documents Required for product registration:

Applications should be submitted in electronic common technical document (eCTD) format.

Module 1: Administrative Information:

1.1 Application form

1.2 Legal and regulatory status of the applicant

1.3 Power of attorney

1.4 Fee payment information

Module 2: Common Technical Document (CTD):

2.1 Common Technical Document Table of Contents (Modules 2-5)
2.2 Introduction
2.3 Quality Overall Summary
2.4 Nonclinical Overview
2.5 Clinical Overview
2.6 Nonclinical Summary and Tabulated Summaries
2.7 Clinical Summary

Module 3: Quality:

3.1 Detailed information on the drug substance and product

3.2 Pharmaceutical development

3.3 Manufacturing process

3.4 Control of drug product

Module 4: Nonclinical:

4.1 Pharmacology and toxicology data

Module 5: Clinical:

5.1 Clinical study reports

5.2 Integrated summaries of safety and efficacy

Regulatory Procedures:

  • Cover letter
  • Orphan designation application (if applicable)
  • Pediatric investigation plan (if applicable)

New Drug registration in Europe Include the docs/modules required

For New drug registration in Europe involves submission to the European medicines Agency (EMA) for Marketing Authorization Application (MAA). This process is carried out through a centralized procedure that allows marketing authorization in all member states of EU.

Module 1: Administrative Information

  • Application Form (administrative details, proposed brand and information of their contact)
  • Letter of Authorization: A letter Authorizing the applicant to use the other party’s data (IF ANY)
  • Manufacturing site
  • SmPC (summary of product characteristics) and PIL (Patient Information Leaflet).
  • Fees

 Module 2: Quality Overview Summary (QOS):

  • Overview of manufacturing and control data
  • Drug substance and drug products information
  • Manufacturing process summaries
  • Quality control tests and specification
  • Stability Data
  • Nonclinical and clinical summaries
  • Literature references

Module 3: Quality

Provide detailed information on quality of drug, including the manufacturing process, control and stability data.

Module 4: Nonclinical

  • Summaries of all pre-clinical studies conducted
  • Pharmacology, toxicology, pharmacokinetics data
  • Safety assessment
  • Justification for human clinical trials

Module 5: Clinical Studies Data

  • Detailed reports on all clinical trials conducted
  • Study design, patient groups, and methodology
  • Efficacy and safety analyses
  • Statistical evidence and discussion

Centralized Procedure

  • Allows applicants to obtain a marketing authorization valid throughout the European Union (EU).
  • Accepts applications for products in the fields of biotechnological sciences and New Chemical Entities (NCEs).
  • Biotechnological products are categorized as “List A,” and NCEs are categorized as “List B.”

Application Acceptance and Categorization:

  • Applications are accepted for biotechnological products (List A) and New Chemical Entities (List B).
  • Only a single marketing authorization is required for the entire EU.

EMA Review Process:

  • EMEA staff checks the completeness and compliance of the Marketing Authorization Application (MAA) with EU guidelines within ten days of filing.
  • EMEA has 210 days to evaluate the application, appointing rapporteurs to assess and report to the Committee for Medicinal Products for Human Use (CHMP).

CHMP Opinion:

  • CHMP provides an opinion on whether to accept or reject the application.
  • The opinion is forwarded to the European Commission.

Decision by European Commission:

  • The European Commission takes 90 days to make a final decision.

Total Approval Timeline:

  • The entire approval process takes around 300 days (210 days for evaluation + 90 days for the European Commission decision).

Recognition by All Member Countries:

  • A single application to the European Medicines Agency (EMA) results in recognition by all EU member countries.
  • Examples include Certificate of Suitability (CEP) submissions, electronic Drug Master Files (eDMF), and Common Technical Document (CTD) submissions for special products.

Exclusions from Centralized Procedure:

  • Certain product types are excluded from the centralized procedure, and rejection under these schemes bans entry to the EU.
  • Excluded products include Orphan Medicinal Products, all biotechnology-based products, specified AIDS and cancer medicines, specified antiviral medicines, specified medicines for neurodegenerative disorders (including diabetes), and specified medicines for autoimmune diseases/dysfunctions.

Results in a Single Authorization Valid in EU and Associated Countries:

  • The approval results in a single authorization valid not only in the EU but also in Norway, Iceland, and Liechtenstein.

Application Evaluation by Assigned Reporters:

  • Assigned rapporteurs assess the application during the evaluation process.

Compulsory for Specific Medicines:

  • The centralized procedure is mandatory for medicines derived from biotechnological processes (genetic engineering).
  • It is also compulsory for medicines intended for the treatment of cancer, HIV/AIDS, diabetes, neurodegenerative disorders, autoimmune diseases, and other immune dysfunctions.
  • Medicines officially designated as ‘orphan medicines’ (used for rare diseases) are also subject to the centralized procedure.

Decentralization Procedures:

  • This process involves obtaining marketing authorization in several European Union countries at the same time.
  • In some countries, it is considered an effective process to obtain approval for medicinal products.

Submission process:

  • The sponsor submits an application to the national supervisory authority with a list of all Member States (CMS) concerned.
  • The program indicates the reference member state (RMS).

Role of the Reference Member State (RMS):

  • RMS approves the program and summary product specification (SPC).
  • Within 210 days, RMS prepares a draft assessment report and sends a copy to CMS.

Approval process:

  • CMS has 90 days to approve the evaluation report.
  • CMS may object if there are public health concerns.

CHMP intervention:

  • If there are objections, the Committee for Medicinal Products for Human Use (CHMP) intervenes.
  • The CHMP resolves all disputes between member states and takes a final decision within 30 days.

Limitation of products eligible for decentralized processing:

  • Veterinary Medicine: Medicines for rare diseases cannot be used.
  • Products based on biotechnology: Features refer to products produced through biotechnology processes.
  • Prescribed help with cancer drugs: Certain drugs for AIDS, cancer and other specific diseases may not be suitable.
  • Antiviral specific: specifically applied to certain antiviral medications.
  • Specific drugs for neurodegenerative disorders: Certain drugs for neurodegenerative disorders, including diabetes, cannot be used.
  • Autoimmune Diseases/Specific Medications: Certain medications for autoimmune diseases or dysfunctions may not be included.
  • Effect of decision:

A negative decision in the decentralized procedure may affect the simultaneous registration of medicinal products in several countries.

Product type:

  • The decentralization procedure excludes several categories of products, especially those considered essential for certain diseases or based on certain technologies.