Drug Registration Process in Europe

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.