August 2022 Monthly Newsletter

PLG as Interim Marketing Authorisation Holder

ProductLife Group not only offers support throughout all phases of the development of a pharmaceutical product, but is also able to act as the applicant for a Marketing Authorisation Application in the EU on your behalf. All it takes is a Letter of Authorisation and while our experts provide you with consulting and hands-on support in preparing the required regulatory and scientific documentation, we will take care of all the administrative paperwork and communication involved in such a process.

ProductLife Group‘s leading strategy in Regulatory & compliance services explained by its CEO, Xavier Duburcq, and CHRO, Candice Bosson

Navigating the EAEU legislative changes for Medicinal Products

The Eurasian Economic Union (EAEU), consisting of: Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia, are in the process of unifying the regulatory framework around the licensing of new pharmaceuticals and medical devices. The changes to the legislation seek to update the drug submission process ensuring that all registered medicinal products comply with the new standards by 2025.

Over the last few years, there have been multiple updates and amendments to the legislation surrounding the licensing process. Recent changes have affected the timeline for products currently in the registration process. In addition, the costs of new drug submissions, renewals and upgrades have gone up by a factor of two to threefold.

Brazil – Shorter Timelines for CTA (Clinical Trial Applications) Assessment

Brazil has a longstanding tradition and experience of performing clinical trials, with a good infrastructure of investigational sites, laboratories, and medical professionals. With its large and diverse population – over 200 million inhabitants – from different origins and ethnicities, and a high incidence of diseases prevalent in developed regions, the country offers favorable conditions to conduct trials across diverse medical fields.

However, before starting a clinical study, the Clinical Trial Application (CTA) must be evaluated by the National Health Surveillance Agency (ANVISA) and Ethical System. The historically long timelines required for these assessments represent one of the main reasons Brazil does not participate as actively as other nations in international multicenter studies.

The Implementation of the EU Clinical Trial Regulation 536/2014

On the 31^st of January 2022, the European Union (EU) initiated the transition from the Clinical Trial Directive (CTD 2001/20/EC) to the Clinical Trial Regulation (CTR 536/2014). The main purpose is to streamline the Clinical Trial Application (CTA) and enhance the assessment and supervision of clinical trials among the EU Member States.

August 2022 Monthly Newsletter

PLG as Interim Marketing Authorisation Holder

PLG's CEO & CHRO interview on BFM TV

Navigating the EAEU legislative changes for Medicinal Products

Brazil – Shorter Timelines for CTA (Clinical Trial Applications) Assessment

The Implementation of the EU Clinical Trial Regulation 536/2014

Register to our news and events