Regulatory framework for clinical trials on medicinal products for human use

This compilation of the regulatory framework governing clinical trials on medicinal products for human use should not be regarded as complete, as both new legislation and changes to existing framework may be introduced. However, the consolidated versions of the various legal acts incorporate the adopted amendments.

Clinical Trials Regulation (CTR)

A new European common Clinical Trials Regulation on clinical trials on medicinal products for human use, (EU) No 536/2014, applies in all member states and countries belonging to the European Economic Area (EEA) from 31 January 2022. The Regulation (also called the CTR) repeals the national legislation based on Clinical Trials Directive 2001/20/EC.

During a transition period of three years, specific rules applies to facilitate the transition from the Directive to the Regulation. The national laws and other legislations concerning clinical trials that describe, among other things, the work of the Swedish Medical Products Agency (Swedish MPA) and the Swedish Ethical Review Authority, have been adapted to the new Regulation.

The Regulation applies to clinical trials on medicinal products for human use, regardless of whether or not they are commercial, and thus also includes academic research.

More information on Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC, including e.g. templates developed at EU level, can be found on the European Commission’s website, EudraLex.

The website includes:

• a guidance document about CTR (Questions & Answers Document – Regulation (EU) 536/2014)
• a guidance document about CTR and IVDR (Q&A on the interface between Regulation (EU) 536/2014 and Regulaton (EU) 2017/746)
• Risk proportionate approaches in clinical trials.

National provision related to CTR (only available in Swedish):

Note that LVFS 2011:19 and the associated guidance do not apply to clinical trials under Regulation (EU) No 536/2014.

Clinical Trials Directive

Information on Directive 2001/20/EC and related documents can be found on the European Commission’s website, EudraLex.

Click ‘Set of documents applicable to clinical trials authorised under Directive 2001/20/EC’. The website includes a guidance document, Draft – Questions & Answers Document.

Läkemedelsverkets föreskrifter (LVFS 2011:19) om kliniska läkemedelsprövningar på människor. Note that this provision only applies to clinical trials on medicinal products in humans conducted under national legislation based on Directive 2001/20/EC.

Guidance on clinical trials on medicinal products in humans conducted under national legislation based on Directive 2001/20/EC (Swedish).

Other regulations

Läkemedelsverkets föreskrifter (HSLF-FS 2021:95) om partihandel med läkemedel

Läkemedelsverkets föreskrifter och allmänna råd (LVFS 2004:7) om tillstånd för tillverkning och import av läkemedel

Läkemedelsverkets föreskrifter (LVFS 2004:6) om god tillverkningssed för läkemedel

Läkemedelsverkets föreskrifter och allmänna råd (LVFS 2004:10) om avsiktlig utsättning vid klinisk prövning av läkemedel som innehåller eller består av genetiskt modifierade organismer

ICH guidelines

Declaration of Helsinki

Guideline – First-in-human study

First in human