As part of the new contacts and professional growth of ESPL, a regular news letter is made to keep ESPL contacts upto date with European news. Please see below. A link has been attached if youd liked to download and share internally. ESPL-newsletter-issue12-1Q2022
With the end of 2021 fast approaching, it is worth reflecting on a year that has seen a lot of regulatory changes. For many, the first challenge was Brexit on 1st January. This included the implementation of UK national processes, and Centrally Authorised medicines transitioning to UK PLGB licences, via the MHRA Submissions Portal. For Devices, the full implementation of …
As part of the new links and growth of ESPL, a regular news letter is made to keep ESPL contacts upto date with European news. Please see below. A link has been attached if youd liked to download and share internally. ESPL-newsletter-issue10-oct2021
ESPL as a company was established on 16 July 1996. Today we celebrate 25 years. During that time the company, that started as an electronics consultancy by Tony Erwood, and then re-focussed on Regulatory Affairs following Helen’s joining in 2000, has grown to become an employee-owned business offering expert regulatory support across a wide range of areas. We support pharmaceuticals, …
ESPL is excited to announce the launch of its new website. With the support of Highlands and Islands Enterprises (HIE), ESPL has worked with Denvir Marketing to create a new website to provide visitors with a modern, easy-to-navigate, overview of our company and services. As we know, in this connected-technology era, having a website that provides clear and insightful information …
MAHs should review their manufacturing processes to identify and, if found, to mitigate risk of presence of nitrosamine impurities. The deadline for provision of the step 1 responses has been extended for an additional 6 months to 1 October 2020. This deadline is subject to review in light of the ongoing Coronavirus (COVID-19) outbreak and any further changes will be …
Advice for investigators and sponsors of ongoing clinical investigations and new applications.
We are producing guidance and information for industry, healthcare professionals and patients covering the coronavirus (COVID-19) outbreak. The MHRA is working closely with DHSC and other healthcare partners on COVID-19. We are prioritising work including: Supporting and authorising the development of vaccines Clinical trials of new medicines Managing the supply of medicines and healthcare products Read more here
As researchers race to develop vaccines and therapeutics against COVID-19, EMA has published an overview of how the Agency will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures described in PDF iconthe inventory can accelerate every step of a medicine’s regulatory pathway …
In a high-level meeting on COVID-19 policies, organised by EMA under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators from around the world discussed strategic issues and regulatory approaches to ensure a coordinated response to the pandemic. They stressed the need for alignment on pre- and post-authorisation regulatory requirements to facilitate the rapid development, evaluation …