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Posts Tagged ‘EMA’

EU-US Mutual Recognition Agreement for inspections

May 8, 2019


With the Mutual Recognition Agreement between Europe and the US, inspections are to be mutually recognised in the future. The FDA’s approval of the EU Member States proceeds successively. Two more countries have recently been approved: Bulgaria and Cyprus. That makes 24 approved EU states so far. There are 4 countries left: Germany, the Netherlands, Luxembourg and Slovakia. By 15 July, 2019 though, all authorities and countries are supposed to have been reviewed and approved. Regular updates may be found in a question and answer document on the EMA’s website.

Encoding errors in the Article 57 database of EMA

April 9, 2019


The FAMHP  Vigilance department has found several encoding errors in the Article 57 database of the EMA. Some medicines licensed in Belgium appear two or three times in the database, in two or three national languages. As a result, they are registered multiple times for the same marketing authorization (MA). Every medicine may only be coded once based on the MA number (BE #).

As MA holders are encouraged by EMA to carefully check and correct the registered entries of their different medicines in the database if necessary, FAMHP is asking marketing authorization holders to check whether their registered data are correct.


More information can be found here.

New EMA pilot project helps to facilitate validation of initial marketing authorisation applications

March 15, 2019


EMA launched a five-month pilot study to increase the correct submissions of initial marketing authorisations applications (MAAs). The pilot is a result of the 2016 EMA survey that showed validation issues occur in 90% of all initial applications.

The pilot study consists of an authomated checklist that will help companies assess the level of completion and consistency of the various sections in their application. EMA encourages applicants to submit the validation checklist as part of the MAA dossier. In addition, comments to the checklist may be sent to for further evaluation and improvement of the current validation process.

More information can be found here.

New EMA regulations 2019/5 and 2019/6

January 28, 2019

European Union

On January 7th, 2019 regulation 2019/5 was published in the Official Journal of the European Union “amending Regulation 726/2004, known as the Regulation on the Centralized Procedure. The new Regulation will apply from 28 January 2019.

Regulation 2019/5 combines and integrates the “key elements” of following rules into Regulation 726/004:

–       The rules on conditional marketing authorizations, currently contained in Regulation 507/2006

–       The rules on variations, currently in Regulation 1234/2008 (These rules have also been integrated in Directive 2001/83/EC)

–       The rules on financial penalties that may be imposed on marketing authorization holders of centralized authorizations, who fail to comply with their obligations, currently set out in Regulation 658/2007.

These consolidations are accompanied by several changes within these rules. In several cases, this new Regulation empowers the Commission to adopt new delegated acts that complement the “key elements” now contained in the centralized procedure regulation. In addition to these changes, this new Regulation also describes the financing of EMA.

Regulation 2019/6 removed the rules on veterinary medicinal products from Regulation (EC) No 726/2004 on the centralized procedure and the current Directive 2001/82/EG on veterinary products at national level was repealed.

This new regulation just entered into effect in all member states of the European Union. From now on, all parties involved have three years to ensure compliance with the obligations in this Regulation. The health authorities and all parties involved will make the necessary preparations, at both national and European level to ensure the implementation of this new regulation.

Regulation 2019/6, which will apply as of 28 January 2022, covers all the routes granting marketing authorization for veterinary products in the Union – both at centralized and national level. It should provide more innovation, increase the availability of veterinary medicines by simplifying the regulatory pressure and administrative burden and increase the competition in the veterinary pharmaceutical sector. In addition, a key point of this regulation is to strengthen existing EU laws against antimicrobial resistance. The safeguarding of public health, animal welfare and animal health and the protection of the environment remain the central focus point.

More information can be found here.



New GVP Product- or Population-Specific Considerations IV published by EMA

December 19, 2018


EMA published the new good pharmacovigilance practice (GVP) Product- or Population-Specific Considerations IV containing specific considerations about pharmacovigilance for the pediatric population. It explains the importance of pediatric pharmacovigilance, the difference with regular pharmacovigilance and provides guidance on how to best use the current tools and processes to obtain an adapted safety monitoring system in children. In addition, it clarifies the roles and competences of the committees concerned and advises on regulatory requirements for the pediatric population in the European Union.


Updated Annex to the EC guideline on excipients and information in the package leaflet

December 17, 2018


EMA published an updated Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’. The annex contains a list of all excipients known to have a recognised action or effect that need to be displayed on the label of any medicine authorised in the European Union (EU). This annex is reviewed regularly by EMA’s Excipients Drafting Group (ExcpDG) to update the information on excipients or include new excipients. This update reflects a correction of editorial mistakes in the previous version and concerns corrections on the route of administration, the name and the information for the package leaflet for phenylalanine, sodium laurilsulfate and wheat starch, respectively.

The update can be found here.

eCTD mandatory for MRP and DCP

February 5, 2018


As from 1 January 2018, it is obliged to submit the common technical document (CTD) electronically for variations of human medicines, registered via the Mutual Recognition Procedure (MRP) or Decentralised procedure (DCP).

This eCTD format is mandatory for the submission of new marketing authorization applications as well as for submissions regarding on-going regulatory activities, such as follow-up submissions for variations, periodic safety update reports, notifications, responses and renewals. It also includes active substance master file submissions used in European procedures and responses or supplementary information in ongoing MRPs.

More information can be found on the EMA eSubmission website.

EMA moves to Amsterdam

January 24, 2018


Finally, it is decided! The European medicines Agency (EMA) will relocate to Amsterdam following UK’s withdrawal from the European Union. The decision followed an assessment of the bids by the European Commission and EMA. By 30 March 2019 at the latest, EMA should be in operation in Amsterdam.

EMA’s relocation will also impact the continuous supply of medicines for human and veterinary use within the European Union. Marketing authorisation holders, applicants and sponsors of centrally authorised medicines should consider which changes have to be addressed before the United Kingdom leaves the European Union. Necessary changes should be made by 30 March 2019 at the latest. To help pharmaceutical companies prepare for Brexit, EMA has published a procedural guidance and a Questions & Answers document.

Improvement of EMA’s guidance on post-authorization activities

September 13, 2017


The best practice guidelines and support documents for marketing authorization holders (MAHs) have been updated by EMA. The amendments involve topics concerning type II variations, post-authorization safety studies (PASS) and changes related to quality aspects.
The most important updates are:

  • A new pre-submission checklist for type II variation applications. This validation checklist will help applicants to submit complete and correct type II variation packages.
  • An updated Q&A for PASS with 15 new questions and answers. This Q&A includes detailed information on submission requirements, assessment and implementation of outcomes for protocols, protocol amendments and final study reports of non-interventional imposed PASS.

An update of the ‘Classification of post-authorization changes – Quality aspects’. Eight new Q&As to advise MAHs on post-authorization procedures, including additional variation classification categories.

EMA’s relocation is delayed

September 11, 2017


The relocation of the European Medicines Agency (EMA) due to Brexit will take longer than expected. Nineteen countries offered to host EMA and especially the Netherlands are very interested to become EMA’s new home base. One of the reasons for this is the creation of many jobs resulting in several economic benefits.

The host country has to fulfill 6 criteria to be an appropriate candidate. The most important criterium is the ability for EMA to be functional immediately following Brexit. Also important are accessibility, international schools, jobs and care for partners and children, operational continuity and geographical distribution. By the end of September, EMA will publicly share its evaluation. The voting will take place in November and the final decision will be announced 20 November 2017.

Also Belgium applied, so that the best may win!