Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Making the Most of the EU's Regulatory Resources

This article was originally published in SRA

Executive Summary

The European Generic medicines Association's 8th regulatory and scientific affairs conference took place on 29-30 January in Amsterdam. The event covered a number of issues affecting the generic medicines sector, such as making the most efficient use of existing resources by national competent authorities in order to achieve an efficient regulatory system in Europe, improvements to the variations regulations that will affect both authorities and industry, and the implementation of electronic submissions. It also discussed current experience and advice on how to update the patient information leaflet and the summary of product characteristics of generic medicines to reflect changes to the reference product, and touched on the European Commission's inquiry into competition in the EU pharmaceutical sector.

You may also be interested in...



Separation Key To Posting Studies Linking Dietary Ingredients To Preventing Or Treating Disease

DSHEA’s Scientific Literature Exemption is attracting attention for offering online studies showing nutrients’ benefits on diseases including COVID-19, though the method isn’t free of risks, suggests CRN executive Megan Olsen.

Hanmi And LG Chem Highlight Vaccine Prowess, Novel R&D At JPM

Hanmi showcases at JPM its contract production capabilities for COVID-19 vaccines as South Korea prepares to bring in candidates from several global developers, while LG Chem highlights progress across multiple pipeline projects.

Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker

UsernamePublicRestriction

Register

OM017175

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel