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

MHRA considers switching ibuprofen gel

This article was originally published in The Tan Sheet

Executive Summary

The Medicines and Healthcare products Regulatory Agency seeks comments on potentially switching Ibuleve Speed Relief Max Strength Gel to full OTC access in the U.K. The topical analgesic currently is available without a prescription from the pharmacist. The drug's maker Diomed Developments Ltd. asked MHRA to switch the 10 percent ibuprofen gel for consumer "convenience." The company makes a similar OTC product with 5 percent ibuprofen, but says the more concentrated product would allow consumers the same therapeutic benefit with smaller volume. The firm also wants the agency to increase the allowable tube size from 2.5 grams to 4 grams. To reduce the risk that consumers familiar with the weaker product would overdose on the more concentrated gel, Diomed would highlight the dose volume on the product packaging. Comments on the switch are due April 28

You may also be interested in...



U.K. boosts ibuprofen gel strength, pack size

The Medicines and Healthcare products Regulatory Agency increases from 5 percent to 10 percent the maximum strength of ibuprofen gel available via OTC sale for local symptomatic relief of pain and inflammation. In a July 8 decision on Diomed Developments Ltd.'s April 2010 request, the agency approved increasing the maximum OTC - or general sale - ibuprofen pack size from 2.5 g to 4 g (1"The Tan Sheet" April 5, 2010, In Brief)

Philips Expert Urges Device Makers: Update Quality Systems To Conform To Revised Risk Standard ISO 14971

It’s time for manufacturers to begin adopting the new 2019 version of ISO 14971, the international standard for risk management widely used by industry. But firms need to do more work than just changing the date on risk-related procedures and documents to “2019,” says Jos Van Vroonhoven, a senior manager at Philips Healthcare who was intimately involved with the standard’s redo. From conducting gap assessments to creating cross-functional teams, both Van Vroonhoven and longtime industry expert Don Powers tell Medtech Insight how firms can keep their quality systems up-to-date to conform to ISO 14971:2019.

Crosswalk: ISO 14971:2007 Vs. ISO 14971:2019

Here’s a crosswalk for recently revised international risk management standard ISO 14971 and its 2007 predecessor.

Topics

UsernamePublicRestriction

Register

PS103972

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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