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New to EU regulatory affairs? Start here
A reading path through EU pharmaceutical regulatory affairs for people new to the field: who decides what, how medicines are authorised and changed, how the dossier is organised, and how to research questions with AI without handing over your judgment. Seven steps, each pointing to a RafiHive guide or insight and to the official sources behind it.
Last reviewed 16 October 2026
1. Who decides what in the EU regulatory system?
Medicines in the EU are regulated by a network, not a single agency. The European Commission grants centralised marketing authorisations on the basis of a scientific opinion from EMA's Committee for Medicinal Products for Human Use (CHMP). National competent authorities authorise medicines nationally and through the mutual recognition and decentralised procedures, which the CMDh coordinates.
Most of the rules come from Directive 2001/83/EC and Regulation (EC) No 726/2004. Both are being replaced by the new EU pharmaceutical package, so learn the current framework and keep an eye on what is changing.
Read on RafiHive
Official sources
2. How does a medicine get authorised: centralised, MRP, DCP or national?
The centralised procedure gives one authorisation valid in every EU member state. It is mandatory for some products, including biotechnology medicines, advanced therapies, orphan medicines and new active substances for conditions such as cancer or diabetes.
Other products can be authorised nationally. If a product is already authorised in one member state, the mutual recognition procedure (MRP) extends that authorisation to others. If it is not yet authorised anywhere, the decentralised procedure (DCP) runs one application in several member states at once, led by a reference member state.
Read on RafiHive
- Centralised procedure variations: the source map for MAHs
- MRP/DCP variations: a pre-submission checklist
- EMA's first phased review reached a positive opinion. Is this the future of EU marketing authorisation?
Official sources
3. How is the dossier organised: CTD, eCTD and Module 1?
Applications follow the Common Technical Document (CTD), an ICH format. Modules 2 to 5 (summaries, quality, non-clinical and clinical) are harmonised across ICH regions. Module 1 is regional: in the EU it holds the application form, the product information and other administrative and national documents.
The eCTD is the electronic format the dossier is submitted in, and its next version, eCTD v4.0, is already being introduced for centralised applications.
Read on RafiHive
- EU eCTD Module 1: what to check before submission
- eCTD v4.0 is coming. Why this is more than a submission format upgrade.
- EU eCTD Module 1 gap check
Official sources
4. How do changes after authorisation work?
Once a medicine is authorised, almost every change to it is a variation: a new manufacturing site, a tighter specification, a safety update to the product information. Variations are classified by risk as Type IA, Type IB or Type II, with extensions for the largest changes, and each class has its own procedure and timetable.
The framework was revised recently. The amended Variations Regulation has applied since 1 January 2025, and new Commission guidelines with new classification codes since 15 January 2026, so older training material may use codes that no longer apply.
Read on RafiHive
- EU variation classification: IA, IB, II or extension?
- EU variations in 2026: what changed and what regulatory affairs teams need to check
Official sources
5. What are the SmPC, package leaflet and labelling?
The summary of product characteristics (SmPC) is the reference information for healthcare professionals. The package leaflet is written for patients, and the labelling covers the outer and immediate packaging. Their structure and standard wording follow the QRD templates that EMA publishes.
Electronic product information (ePI) is set to turn these documents into structured data, which makes consistency between them more important, not less.
Read on RafiHive
- EU packaging and labelling check
- ePI is coming to EU medicines. But digitising product information won't fix bad regulatory data.
Official sources
6. How do you research a regulatory question properly?
What separates a good RA professional is not knowing every answer. It is finding the source that governs the answer, checking that it is current and final, and reading the conditions around the passage. Learn the source hierarchy and a routine for verifying claims before you rely on any tool, AI or otherwise.
Read on RafiHive
- How to research an EU regulatory question without being misled by AI
- Why hallucinated citations are a serious problem in regulatory affairs AI
- Source coverage: what RafiHive's knowledge base contains
Official sources
7. How do you use AI without outsourcing your judgment?
AI agents can take on much of the searching, comparing and first drafting in regulatory work. They cannot accept regulatory risk, choose a strategy or stand behind a submission. Learning early where that line sits is what keeps a tool making you a better professional rather than a dependent one.
Read on RafiHive
- The regulatory affairs professional of the future: what humans should own and what AI agents should do
- What is a regulatory affairs AI agent?
- AI governance and human review
Official sources
Going further: quality and CMC topics
Once the basics are in place, most day-to-day RA questions sit in the quality part of the dossier. These guides cover the topics that come up most often.
This page is a reading order, not training or advice. Confirm current source versions and have a qualified regulatory professional review decisions before use.