Public consultation on the principles and guidelines of good manufacturing practice for active substances in medicinal products for human use - Deadline: 20 April 2012
15/12/2017
Pharma investigations: Commission closes infringement procedure against Roche without penalty
Today, the Commission sent an explanatory statement to Roche informing them about the closure of the infringement procedure taken against them for failure to meet certain obligations related to their marketing authorisations.
For more information, click here
28/11/2016
Evaluation of the EMA fee system – terms of reference for external contract.
DG SANTE has contracted out a study to support the evaluation of the fee system of the European Medicines Agency. The project will start in December 2016 and will last for 15 months.
The document is available here.
06/07/2016
Study on the regulation of advanced therapies in selected jurisdictions.
The documents are available here.
28/06/2016
Launch of targeted stakeholder consultation on the draft Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products.
- Targeted stakeholders
All stakeholders involved in the development, manufacture and/or commercialisation of advanced therapy medicinal products ("ATMPs"). Comments from small and medium-sized enterprises (SMEs) and academia are particularly welcome. - Period of consultation
From 28 June 2016 to 26 September 2016. - Objective of the consultation
Article 5 of Regulation 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC requires the Commission to draw up guidelines on good manufacturing practice specific to advanced therapy medicinal products.
A consultation on this topic was launched in 2015. On the basis of the comments received during the consultation, as well as input from consultation with the European Medicines Agency and competent authorities in the Member States, the Commission services have developed draft Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. With this consultation, the Directorate General for Health and Food Safety wants to give an additional opportunity for concerned stakeholders to express their views on the GMP requirements that should apply to ATMPs.
The comments received will be taken into account by the European Commission to finalise the Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products.
27/06/2016
5th Meeting of the Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) - 28 June 2016 Brussels.
The draft Agenda is now available here.
20/06/2016
Updated Q&A (v.5) on safety feature now available.
For more information, click here.
16/06/2016
Updated Q&A (v.7) on importation of active substances (APIs) now available.
For more information, click here.
01/06/2016
Launch of four public consultations on recommendations related to clinical trials.
Four public consultations on recommendations related to clinical trials are open from 1 June 2016 to 31 August 2016.
For more information, click here.
13/05/2016
Annual report on benefits and infringements under the Paediatric Regulation.
On an annual basis the European Medicines Agency reports on companies and products that have benefitted from the rewards and incentives provided by the Paediatric Regulation No 1901/2006 as well as on companies that have failed to comply with any of the obligations in that Regulation. This report is published by the Commission in accordance with Article 50(1) of the Regulation.
The report covering the year 2015 is available here.
11/05/2016
NTA update of volume 6A.
Deletion of chapter 4. More details can be found here.
09/03/2016
Responses to the public consultations on detailed arrangements for clinical trial inspection procedures including the qualification and training requirements for inspectors pursuant to Article 78(7) of Regulation (EU) No 536/2014.
Responses to these public consultations are available here.
09/03/2016
4th Meeting of the Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) - 10 March 2016 Brussels.
The draft Agenda is now available here.
07/03/2016
Launch of "PRIME" scheme to pave the way for promising medicines.
02/03/2016
Responses to the public consultations on Good Manufacturing Practice for Investigational Medicinal Products.
Responses to these public consultations are available here and here.
02/03/2016
Responses to the public consultations on notice from the Commission on aspects of the application of Article 3, 5 and 7 of Regulation (EC) N° 141/2000 on orphan medicinal products.
The responses to the public consultations are available here.
09/02/2016
New safety features to protect EU consumers from falsified medicines.
The delegated Regulation 2016/161 , published today in the Official Journal, sets out the details of obligatory "safety features" for medicines which will guarantee medicine authenticity and secure the medicine supply chain.
For more information, click here.
29/01/2016
New COMMISSION STAFF WORKING DOCUMENT Inventory of Union and Member State incentives to support research into, and the development and availability of orphan medicinal products — State of play 2015.
22/01/2016
As of 1 February 2016 marketing authorisation holders will no longer be required to submit type IA variations in relation to administrative changes to the Qualified Person Responsible for Pharmacovigilance and the Pharmacovigilance System Master File.
Further details are available here.
22/12/2015
Roadmap on evaluation of EMA fee system.
The roadmap was published on the page of Your Voice in Europe.
Stakeholders may provide feedback by 29/01/2016.
16/11/2015
Public consultations on Notice from the Commission on aspects of the application of Article 3, 5 and 7 of Regulation (EC) N° 141/2000 on orphan medicinal products.
- Period of consultation
From 16 November 2015 to 15 February 2016.
27/10/2015
The 3rd STAMP meeting took place on 20 October 2015.
The agenda and documents of the meeting are now publicly available here.
One of the topics discussed was PRIME - a new scheme to optimise development of priority medicines and facilitate patients' access.
EMA started a public consultation on PRIME on 26 October with the deadline for comments 23 December 2015.
15/10/2015
Eudralex - Volume 4, Annex 16 updated.
A new version of Annex 16: Certification by a Qualified Person and Batch Release has been published. This version will become operational on 15 April 2016.
09/10/2015
3rd Meeting of the Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) - 20 October 2015 Brussels.
The draft Agenda is now available here.
06/10/2015
EudraLex - Volume 2, New module 1.2 paper application form (revision 12 - September 2015).
Following the changes in Chapter 1 published in June 2015, the new version of the AF is now available. The electronic version will be available as from 03/11/2015. It will be mandatory to use the new versions of the AF and eAF as from 30/11/2015 (eAF must be used for centralised procedure applications). It is strongly recommended to use the eAFs for all procedure types considering that the use for all other procedure types will become mandatory from 1st January 2016.
15/09/2015
Consultation on EU GMP Guidelines, revised Annex 17 on the Real Time Release Testing.
Today, DG SANTE launches a consultation on the revision of "Annex 17: Real Time Release Testing".
The consultation is now closed.
28/08/2015
Four new public consultations concerning good manufacturing practices and clinical trials for human medicinal products are opened August 28, 2015 with closing date November 24, 2015.
- Commission Delegated Act on principles and guidelines on good manufacturing practices for investigational medicinal products for human use and inspection procedures.
- Detailed Commission guidelines on good manufacturing practices for investigational medicinal products.
- Commission Implementing Act on principles and guidelines on good manufacturing practice for medicinal products for human use.
- Detailed arrangement for clinical trials inspection procedures including the qualifications and training requirements for inspectors.
24/07/2015
Update of Guideline on the packaging information of medicinal products for human use authorised by the Union (July 2015) are now published.
23/07/2015
Launch of Targeted stakeholder consultation on the development of Good Manufacturing Practice for Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation 1394/2007.
This consultation targets all stakeholders involved in the development, manufacture and/or commercialisation of advanced therapy medicinal products. Comments from small and medium-sized enterprises (SMEs) are particularly welcome.
Period of consultation is from From 23 July 2015 to 12 November 2015.
Objective of the consultation:
Article 5 of Regulation 1394/2007 requires the Commission to draw up guidelines on good manufacturing practice ("GMPs") specific to advanced therapy medicinal products ("ATMPs").
With this public consultation, the Directorate General for Health and Food Safety intends to seek the view of stakeholders regarding the GMP requirements for ATMPs.
The comments received will be taken into account by the European Commission when developing the Guidelines on good manufacturing practice specific to ATMPs.
15/07/2015
EudraLex - Volume 2, NTA update of volume 2A.
An update of Chapter 1 of the volume 2A is published. The changes concern mainly:
- section 2.3 notion of "global marketing authorisation",
- section 5.5 application according to Article 10b of Directive 2001/83/EC,
- section 6.5 one year period of protection for new indications of well-established substances,
- annex I,
- addition in view of deletion of chapter 4.
The corresponding update of the application form will be available in September.
08/07/2015
EudraLex - Volumes 2 and 6, update of notice to applicant.
The use of electronic application forms (eAFs) is now mandatory for all human and veterinary centralised procedure applications (initial MAAs, variations, renewals) since the 1st of July 2015.
Although the eAF is now mandatory for the centralised procedures, the published eAFs could also be used for the other procedures (DCP, MRP and NP).
The User guides for the electronic application forms are available here:
It must be noted that they are not NTA documents.
06/07/2015
On 6 July 2015 the Commission returned the case file concerning the infringement procedure against Roche Registration Ltd to the European Medicines Agency for a new period of inquiry pursuant to Article 15 of the Commission Regulation (EC) No 658/2007. The European Medicines Agency should then adopt a report within one year in accordance with Article 10(3) of the Commission Regulation (EC) No 658/2007.
The European Medicines Agency started the infringement procedure against Roche Registration Ltd in October 2012, following a request of the European Commission, to investigate allegations that the company has failed to comply with pharmacovigilance obligations in relation to its 19 centrally authorised medicines. The European Medicines Agency sent its initial report to the European Commission in April 2014.
More information regarding the infringement procedure is available at the website of the European Medicines Agency.
02/07/2015
Brazil and Israel have been added to the "list of third countries" having standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU.
The Commission Implementing Decision is available here.
02/06/2015
The use of the electronic Application Forms (eAF) is mandatory for Centralised procedure from 1 July 2015.
The eAFs must be used for all Human and Veterinary applications : authorisations, variations and renewals. The eAFs are available here.
29/05/2015
Annual report on benefits and infringements under the Paediatric Regulation.
On an annual basis the European Medicines Agency reports on companies and products that have benefitted from the rewards and incentives provided by the Paediatric Regulation No 1901/2006 as well as on companies that have failed to comply with any of the obligations in that Regulation. This report is published by the Commission in accordance with Article 50(1) of the Regulation.
The report covering the year 2014 is available here.
For more information, see "Medicines for children".
20/05/2015
EudraBook V1 - May 2015 - Compendium of EU pharmaceutical law.
The main body of EU legislation on medicinal products for human use is now available in e-book format.
For more information, see EudraLex
11/05/2015
Good Manufacturing Practices.
The responses to the public consultation on the revision of "Annex 15: Qualification and Validation" are available here.
01/04/2015
Commission report on the use of delegated powers.
The Commission transmitted to the European Parliament and the Council a report on the use of delegated powers provided by the EU pharmaceutical legislation. This follows a legal obligation under Directive 2001/83/EC and Regulation (EC) No 726/2004, which requires the Commission to prepare such report every five years.
The report is available in all EU languages.
01/04/2015
74th meeting of the Pharmaceutical Committee, 17 March 2015.
The background documents and the presentations of the 74th Pharmaceutical Committee are now available here.
31/03/2015
Eudralex - Volumes 2 and 4 updated.
A new version of Annex 15 has been published. This version will become operational on 1 October 2015.
The guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use have been published. A risk assessment as set out in these guidelines should be carried out for excipients for authorised medicinal products for human use by 21 March 2016.
The guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use have also been published and come into operation on 21 September 2015.
For more information, see EudraLex - Volume 4.
The revision 14.1 of the Guideline on the packaging information of medicinal products for human use authorised by the Union is published. The update only concerns the annex of the guideline.
For more information, see EudraLex - Volume 2.
30/01/2015
Eudralex V30 is now available.
Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine.
The EudraLex V30 is similar to the EudraLex section of this web site, but it can be used off-line with the search engine. All the documents are in PDF format and without protection.
For a non-commercial use, Eudralex V30 may be duplicated, shared and the documents may be printed.
30/01/2015
Eudralex - Volume 1 updated.
For more information, see EudraLex - Volume 1.
30/01/2015
EudraLex - Volume 4, Chapters 3 and 5 updated.
New versions of Chapter 3 and Chapter 5 have been published providing transitional arrangements for toxicological evaluation. The chapters are otherwise unchanged – apart from an editorial correction of footnote 2 in Chapter 5 – and become operational on 1 March 2015 for all other aspects.
For more information, see EudraLex - Volume 4.
05/12/2014
Delegated Regulation on GMP - good manufacturing practice for API - Active pharmaceutical ingredient.
General information regarding veterinary medicinal products authorised centralised and nationally (Mutual Recognition and Decentralised procedures) contained in Volume 6A, Chapter 7 General information has been transferred to the EMA and to the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) and the European Medicines Agency (EMA) websites, respectively.
The Guideline on Dossier requirements for Type IA and Type IB Notifications Revision 1 (EudraLex - Volume 6 - June 2006) has been removed from the website as out-of-date. There have been some general format changes to the Volume 6 Notice to applicants and regulatory guidelines for medicinal products for veterinary use, but no other substantial amendments.
For more information, see EudraLex - Volume 6.
24/10/2014
73rd meeting of the Pharmaceutical Committee, 22 October 2014.
For more information, see "Human Pharmaceutical Committee - Meetings".
23/10/2014
New version of Clinical trials.
A complete revision of the chapter on clinical trials has been published on the website.
For more information, see "Clinical Trials".
02/10/2014
Commission Call for Expressions of Interest for the position of member of the Committee for Orphan Medicinal Products (COMP) as representing patient organisations.
This call for expressions of interest relates to the appointment by the Commission of members representing patient organisations at the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency.
More detailed information and application documents are available here.
For more information, see "Orphan Medicinal Products".
30/09/2014
New Commission guideline on paediatric investigation plans.
The Commission publishedon 27 September its new guideline on applications for paediatric investigation plans (PIP) under the Paediatric Regulation (EC) 1901/2006. This update follows a commitment in the 2013 progress report . Amongst other things, it simplifies the structure of the guideline, establishes a list of key elements of a PIP and introduces increased flexibility into the application process. Additionally, new study concepts, such as extrapolation and modelling are better recognised and requirements for the compliance check have been clarified. It is expected that the new guideline will contribute to an efficient and proportionate filing process of paediatric investigation plans.
The text of the guideline in all EU languages is available here.
The new guideline is immediatlly applicable as of today. However, until end of 2014 the European Medicines Agency continues to accept paediatric investigation plans that have been prepared in accordance with the previous guideline.
For more information, see "Medicines for Children".
10/09/2014
Adoption of proposal by European Commission.
On 10 September 2014 the European Commission adopted proposals on veterinary medicinal products and medicated feed. With its proposal on veterinary medicinal products, the Commission aims to tailor legislation on veterinary medicinal products to the needs of the veterinary sector, without jeopardising public and animal health, or a safe environment.
The key documents are available here.
08/09/2014
EudraLex V29 is now available.
Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine.
The EudraLex V29 is similar to the EudraLex section of this web site, but it can be used off-line with the search engine. All the documents are in PDF format and without protection.
For a non-commercial use, Eudralex V29 may be duplicated, shared and the documents may be printed.
03/07/2014
72nd meeting of the Pharmaceutical Committee, 26 March 2014.
For more information, see "Human Pharmaceutical Committee - Meetings".
01/07/2014
New Application Forms for variations and renewals.
New application forms for variations and renewals were published on 10 June 2014. There is a transitional period of 3 months until the 1st October 2014, after which the new application forms is recommended to be used.
24/06/2014
The European Commission adopted the new common EU logo for online sale of medicines through an Implementing Regulation.
Member States have one year from this date to ensure that the provisions on the common logo are applied. Therefore, by mid-2015, all online pharmacies or retailers legally operating in the EU should display the logo.
For more information, see "EU logo for online sale of medicines".
18/06/2014
Study on the risks of environmental effects of medicinal products.
The study on the risks of environmental effects of medicinal products has been financed by the Commission and carried out by an external contractor (BIO Intelligence Service). Its objectives are to characterise the scale of the environmental effects of medicinal products and to identify non-legislative and legislative causes and possible solutions across the entire EU legislative framework. It constitutes a starting point from which the different aspects need to be further validated by the European Commission based on the contributions from the European Medicines Agency, the European Environment Agency, Member States and stakeholders.
For more information, see "Medicines and the environment".
10/06/2014
Notice to applicants, update of variations and renewal application forms (human and veterinary) .
The Notice to Applicants, volumes 2 and 6 have been updated with the publication of the updated application form for the submission of variations and renewal:
- Volume 2C : Human medicinal products - Regulatory Guidelines
- Volume 6C : Veterinary medicinal products - Regulatory Guidelines
The electronic version of the new variation and renewal application forms are made available on the European Medicines Agency website.
06/06/2014
Annual report on benefits and infringements under the Paediatric Regulation.
On an annual basis the European Medicines Agency reports on companies and products that have benefitted from the rewards and incentives provided by the Paediatric Regulation No 1901/2006 as well as on companies that have failed to comply with any of the obligations in that Regulation. This report is published by the Commission in accordance with Article 50(1) of the Regulation.
The report covering the year 2013 is available here.
For more information, see "Medicines for children"
27/05/2014
The New Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was published in the Official Journal on 27 May 2014.
For more information, see "Clinical trials".
26/05/2014
Notice to applicants, medicinal products for human use, volume 2A, chapter 3 Union referral procedure.
The update of chapter 3 of volume 2A of the notice to applicants is published and available here.
12/05/2014
The Commission has uploaded an online questionnaire regarding the application of Regulation (EC) No 470/2009 of the European Parliament and of the Council on Maximum Residue Limits (MRLs).
The aim of this questionnaire is to gather information from authorities and stakeholders on their experiences with the MRL-Regulation. This information is necessary to establish the report on the experiences gained from the application of the MRL Regulation as required by Article 28 of the Regulation. As of today the MRL questionnaire is published on the Europa website "Your Voice" (link provided below).
It would be very much appreciated if you could take the time to respond to the questionnaire as your answers will provide valuable information to the Commission. Please find below some additional information regarding the MRL questionnaire:
- Questionnaire language : English
- Number of questions : 22 questions and additional comments (mostly closed-ended questions)
- Deadline for providing answers : May 31 2014 – 20:00 CET
You can only submit/save the questionnaire once it is 100% completed. Therefore, we strongly recommend that you print the questionnaire (PDF format is available online) and prepare the answers in your own time. Once you are ready to submit it you can simply select and copy/paste your answers. You can only stay logged on for a maximum of 60 minutes.
For more information, see "Medicinal products for veterinary Use".
02/05/2014
One-year report on human medicines pharmacovigilance tasks of the European Medicines Agency.
The report on the pharmacovigilance tasks of the European Medicines Agency that were completed the during the first year of application of the EU's new pharmacovigilance legislation is available here.
For more information, see "Medicines for children".
02/05/2014
Responses to the public consultation on the Commission guideline on paediatric investigation plans.
A public consultation took place from 9 October 2013 to 3 January 2014 on the Commission guideline on paediatric investigation plans.
Overall, the Commission received 26 responses. A summary of the comments as well as the replies are available here.
For more information, see "Medicines for children".
16/04/2014
The new Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was adopted on 16 April 2014.
01/04/2014
Report on the application of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products.
The European Commission has adopted a Report on the application of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products ("ATMP Regulation") . In the report, the Commission takes stock of the situation of advanced therapy medicinal products in the EU and analyses the impact of the Regulation on advanced therapies.
For more information, see "Advanced therapies".
01/04/2014
Good Distribution practice.
A Question and Answer document (version 1.0 March 2014) responds to frequently asked questions in relation to the guidelines on Good Distribution Practice of medicinal products for human use.
For more information, see "Good Distribution Practice".
28/03/2014
Revision of the Guideline on the format and content of applications for designation as orphan medicinal products.
On 28 March, the European Commission published the revised EU guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another. The European Commission reviewed the guideline to clarify how sponsors should define the medical plausibly of their product in relation to a disease and its significant benefit. In addition, the electronic submission of an application using the common Food and Drug Administration-European Medicines Agency application form will be possible. During the development of the product, the classification of a disease may change and the designated condition may need to be modified to better reflect the indication that the sponsor intends to request at the time of marketing, therefore, an existing designation can now be amended.
- EU guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another (March 2014)
- Annex to Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another: [PDF version] - [Word version]
For more information, see "Orphan medicinal products".
12/02/2014
71th meeting of the Pharmaceutical Committee, 23 October 2013.
For more information, see "Human Pharmaceutical Committee - Meetings".
06/02/2014
Revision of European Commission Guidelines on Good Manufacturing Practice for Medicinal Products.
Today the European Commission has launched the public consultation on the revision of Annex 15: Qualification and Validation.
For more information, see "Quality of medicines and Good Manufacturing Practices (GMP)".
For more information, see "Maximum Residue Limits".
Details
- Publication date
- 20 January 2012
- Author
- Directorate-General for Health and Food Safety