Argentina

July 2020: EMA Exceptional Transparency Measures

During the COVID-19 pandemic, EMA is implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 that are approved or are under evaluation.

EMA is achieving this by shortening its standard publishing timeframes and publishing information it does not normally publish for other medicines.

Under this practice, the clinical trial data for COVID-19 medicines will be published on clinical data website after marketing authorisation. As a standard practice, such publication is suspended until further notice for other medicines.

July 2020: EU Fine-Tunes Guidance For New Clinical Trials System – A Pink Sheet Article

The Pink Sheet article dated July 17^th reported on a July 1^st session at the DIA Europe 2020 Conference on “Clinical Trial Regulation: State of Play – Are We Ready?”. Judith Creba speaking on behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA) addressed industry’s preparedness for the new legislation noting “We are as ready as possible, but there are still some unclear aspects, mostly related to CTIS which is understandable as it is still under development.” Creba, who is leading the CTR’s implementation within Novartis, said the key thing needed to help get the industry fully ready was to provide companies with access to a ‘test’ CTIS database to help them understand how the system works in practice. Both Creda and Rüdiger Pankow of Parexel, raised concerns that many in industry have previously echoed concerning lack of any inside knowledge of the CTIS under development which makes it challenging to have updated internal standard operating procedures to reflect the new procedures and allow for training prior to implementation of the CTR.

Agnès Mathieu-Mendes, deputy head of the unit dealing with the quality, safety and innovation of medicinal products in the Commission’s Directorate General on Health and Food Safety, also stated that a number of new guidance documents and templates are being prepared to help the industry prepare for the legislation. Work is ongoing to develop new Q&A documents on CTR “hot topics,” such as classification of substantial and non-substantial amendments to a clinical trial, and allowing post-trial treatment access to participating subjects.

The CTIS audit is slated to begin in December 2020 with a proposed ‘Go-Live’ date of CTIS (as well as CTR implementation) in December 2021.

July 2020: Medical Device Regulation (MDR) Update

As per the State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR, the priority action for transparency was to issue a fact sheet on information to become publicly accessible.

This Factsheet on MDR requirements for Transparency and Public Information has been published on July 15, 2020. Most of the requirements on Transparency and public access to information are linked to the Eudamed, which is planned to become fully functional by May 2022.

The transparency requirements under the MDR can be divided into different categories:

Information on medical devices made accessible to the public in Eudamed
Information which is pro-actively made publicly available outside Eudamed by the Commission, the national competent authorities, the industry or the notified bodies

Thus, the fact sheet has presented the MDR transparency requirements separately depending on whether they will be available in or outside the Eudamed database.