Clinical Pharmacology · MU Sofia

13. Drug regulation. Registration of drug use in the EU.

Explains how medicines are regulated in the EU, from the shared roles of the EMA, the European Commission and national agencies such as the Bulgarian Drug Agency. Compares the four marketing authorisation routes (centralised, decentralised, mutual recognition and national) in a table, then lists which drugs must use the centralised procedure. Also covers what a licence contains, special forms of approval, and post-authorisation safety monitoring, including the black inverted triangle and PRAC review.

Inside: 4 sections · 1 table · 16 flashcards · 2 min

Topic 13 of 30 in the MU Sofia syllabus for Clinical Pharmacology (Medicine, Year 5). The free AceMed note covers it in 4 sections, about 239 words (2 min of reading), with 16 flashcards.

In this note

  1. Introduction
  2. Marketing authorisation procedures in the EU
  3. What a licence includes
  4. Safety after authorisation

Introduction

Medicines are regulated so that only products with proven quality, efficacy and safety reach patients, and so that their safety is followed throughout their life. In the EU this is shared between the European Medicines Agency (EMA), the European Commission and the national agencies (in Bulgaria, the Bulgarian Drug Agency).

Marketing authorisation procedures in the EU

Mandatory for the centralised procedure

  • Drugs for HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and viral diseases.
  • Biotechnology products (recombinant proteins, monoclonal antibodies).
  • Advanced therapies (gene therapy, somatic cell therapy, tissue engineering).
  • Orphan drugs (rare diseases).

What a licence includes

  • Data on quality (manufacture under GMP), non-clinical studies and clinical trials (efficacy, safety).
  • The approved SmPC (Summary of Product Characteristics) for professionals and the package leaflet for patients.
  • A risk management plan and pharmacovigilance system.
  • Special forms: conditional approval (more data still required), approval under exceptional circumstances, accelerated assessment.
  • Generics are approved by proving bioequivalence with the reference product; biosimilars by comparability studies.

Safety after authorisation

  • Additional monitoring (black inverted triangle ▼) for new active substances and biologicals authorised after 1 January 2011, conditional approvals, and drugs with required post-authorisation studies; reviewed monthly by the PRAC (Pharmacovigilance Risk Assessment Committee); usually for 5 years.
  • Periodic Safety Update Reports (PSURs) from the marketing authorisation holder; EudraVigilance database; regulators can change the SmPC, restrict, suspend or withdraw a drug.

Innovative drugs for cancer, HIV, diabetes and other key diseases, biologicals and orphan drugs must go through the EMA's centralised procedure, and their licence is valid in the whole EU.

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