Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UK Claims World First With ‘Point Of Care’ Manufacturing Rules

MHRA Says New Rules Will Increase Availability Of Innovative New Products

Executive Summary

The MHRA says its proposals for a new, tailormade regulatory regime for personalized medicines manufactured at the point of care are evidence of its “intent to move away from a common perception of regulators as a progress blocker to a progress enabler.”

You may also be interested in...



Twenty Questions: How Should The US FDA Regulate Distributed Drug Manufacturing?

What happens when manufacturing plants are moving targets? When quality systems are at once more centralized and dispersed? When plant operators are health care workers? Agency wants input before settling on the answers.

Industry Urged To Share Potential Regulatory Challenges To Decentralized Manufacturing

In a world where pharmaceuticals could be manufactured with no fixed address, industry and regulatory authorities must work together to interpret site-based compliance requirements, expert says. New concepts like the MHRA-proposed hub-and-spokes model could play key role.

Robotic Aseptic Filling Could Help Production, But Faces Regulatory Inconsistency

Use of robotic aseptic manufacturing techniques is increasing, but regulatory agencies are giving conflicting feedback, according to an industry executive. The dilemma points to the need for more development of and consistency in regulation for advanced manufacturing.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS144789

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