The selection of a starting material for the synthesis of an active substance and its justification is often one of the most crucial steps in the approval process. Assessors at regulatory agencies of the EU member states have to evaluate whether the data provided sufficiently justify the selection. The criteria for this are outlined in the 2012 ICH Q11 guideline – however, not in a sufficiently precise manner.
It was 2011 when FDA published their Guidance for Industry: Process Validation: General Principles and Practices.
This document radically changed FDA interpretation of process validation.
According to the guidelines validation means “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.” It will no longer be a formalized activity that is limited in time and, typically, to three validation batches.
In May 2017 the EU Commission and EMA made a clear statement: after 30 March 2019 the Unit Kingdom will become a ‘third country’.
In a common Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use, the Commission and the Agency get the point strait that “all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019, 00:00h (CET). That means that the U.K. will “become a ‘third country'”.
On 5 April 2017, 2 new Regulations on medical devices were adopted. These replace the existing Directives.
Regulation (EU) 2017/745 on medical devices
Regulation (EU) 2017/746 on in vitro diagnostic medical devices
The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators.