2. Legislative documents governing medicines regulation

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Course: Introduction to Regulatory Affairs
Book: 2. Legislative documents governing medicines regulation
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Date: Friday, 30 September 2022, 8:39 AM

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1. Legislative documents governing medicines regulation

In the European Union (EU), nobody can market a medicine without holding a marketing authorisation (MA) from the regulatory authorities. A MA should only be granted to medicines fulfilling the above basic requirements – i.e., they are effective and sufficiently safe.

The rules needed for obtaining and maintaining a MA are laid out in a series of legislative documents of different status:

  • Regulations and directives.
  • Guidelines
  • Other types of documents.

1.1. Regulations and directives

    • “Regulations” are legal acts that apply automatically and uniformly to all EU countries as soon as they enter into force, without needing to be transposed into national law. They are binding in their entirety for all EU member states (MS), but certain provisions may apply.
      For example, the Clinical Trials Regulation (CTR) ( Clinical Trial Regulation EU No. 536/2014 ) aiming at harmonizing and simplifying the conduct of Clinical Trials was adopted and entered into force in 2014. The timing of its application depends on confirmation of full functionality of a Clinical Trials Information System (CTIS). The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation. When the Regulation becomes applicable, it will repeal the currently effective EU Clinical Trial Directive (EC) No. 2001/20/EC and national legislation that was put in place to implement the Directive (see next paragraph)

  • A “directive” is a legislative act that sets out a goal that all EU countries must achieve. The member states must introduce the requirements of the directive into their national legislation. However, it is up to the individual countries to devise their own laws on how to reach these goals, as long as they do not weaken the overall goal of the directive.
    For example, Directive 2001/83/EC states that you cannot market a medicine in the EU without having a MA. This requirement is now in the national law of each MS.

You can find all regulations and directives on the website of the European Commission https://ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume-1_en

1.2. Guidelines

The rules given in regulations, directives and national law are not always very detailed. Therefore, both industry and regulatory authorities may need more detailed information on precisely what they should do and how.


 The European Medicines Agency and the European Commission have developed a large number of detailed documents giving the required guidance; they are called guidelines

A guideline is a document providing guidance on the scientific or regulatory aspects of the development of medicines and applications for marketing authorization among others. Although guidelines are not legally binding, applicants need to provide sound justification for any deviations.

Guidelines are very important tools for companies and regulators in their daily work, and are an important advocacy tool for patient organisations. When a company plans the development and establishes the documentation needed for a new medicine, they should carefully consider all recommendations of the guidelines. When regulators assess the documentation, they check whether the company has respected relevant guidelines (see also below “Implementation and status”).


1.3. Other types of documents

Other types of documents have been produced in the past, for example, “Position Paper” or “Points to consider”. These documents expressed the view of the EMA Scientific Committees and provide advice on:

• A selected area of medicinal product development where limited experience is available and knowledge is evolving fast, requiring easy updates and flexibility of the document;

• Interpretation of guidelines or of technical requirements in the legislation;

• Further elaboration of specific issues addressed in guidelines, for incorporation into the guideline upon its next revision.

In substance, the documents referred to above (historical documents) also provide some guidance, but instead of the former terminology, the unique term “guidelines” is used and any distinction with respect to limited experience and/or the need for ongoing revision will be clearly outlined within the scope of the respective guideline.