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Regulation/Legislation (Health)

Set Alert for Regulation {Health}

Supply Of 'Important' OTCs From EU Prioritized In Event Of No Deal Brexit

In preparation for a possible no deal Brexit, the UK government is prioritizing supply from the EU those OTC medicines deemed "important for the management of specific health conditions." The Department of Health and Social Care says it is continuing to work closely with OTC manufacturers and suppliers to prepare for Brexit.
Brexit OTC Drugs Regulation

Bayer's Canesten Switched From Rx-To-OTC Status In Poland

Poland's drug regulator, URPL, has switched Bayer's Canesten vaginal yeast infection treatment from prescription-to-OTC status. It is the regulator's fourth switch in 2019 alone.
Prescription To Otc Switch Poland OTC Drugs

EMA Updates Herbal Monographs For Artichoke Leaf And Buckthorn Bark

The EMA's Herbal Medicines Products Committee (HMPC) has updated EU herbal monographs for artichoke leaf and buckthorn bark.
Health OTC Drugs Regulation


Set Alert for Regulation {Health}

Latest From Health & Regulation

AESGP Conference Round-Up: Digital Disruption, Med Device Worries And The Benefits Of Switching

Speakers from the EMA and European Commission, as well as Pfizer and HRA Pharma, debated at the AESGP's Regulatory Conference the ongoing digital transformation of the European consumer healthcare market, the latest developments in the implementation of the new medical devices regulations, and the best ways to encourage Rx-to-OTC switching across the EU.
Europe Health

Industry Groups To Request FDA Rulemaking Deferrals For Sunscreen Ingredients In Question

Trade groups PCPC and CHPA say they likely will request that FDA defer further rulemaking on sunscreen ingredients that require additional data to retain their GRASE designations under the agency’s proposed rule for a final OTC sunscreen drug monograph, issued in February. For now, the associations are asking for an extension of the allotted comment period beyond May 28, 2019.

FDA Regulation

OTCs Under Threat In Europe: Calls To Reverse-Switch Codeine And Others In Poland And Ireland

Poland's ministry of health is calling for codeine, dextromethorphan and pseudoephedrine to be reverse-switched from OTC to prescription status in response to abuse of the drugs by adolescents. At the same time, an academic paper argues Ireland should restrict codeine to prescription-only sale to combat an addiction epidemic "verging on eruption."
Prescription To Otc Switch Poland
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Set Alert for Legislation {Health}

Latest From Health & Legislation

FDA $6.1Bn Budget Proposal Includes $28M From OTC Monograph User Fees

White House budget request published March 11 proposes a $643m increase in FDA's total FY 2020 funding, with $281m of the increase from FY 2019 in user fees and $362m from the agency's budget authority. Request includes OTC monograph user fees again, increased by $6m.

OTC Drugs Legislation

With High Profile At FDA, Gottlieb Headed Ambitious Consumer Health Initiatives

Scott Gottlieb claimed higher profile than most previous FDA commissioners with frequent Twitter posts and by including his remarks in many agency communications to industries and consumers. In his nearly two years in post, he also had more central role in FDA initiatives in areas such as keeping unsafe products labeled as supplements off the market and explaining why hemp and CBD are available and supplements even though FDA considers the products noncompliant as dietary ingredients.

Beauty Health

Nearly 9% FY 2019 Increase For FDA In Shutdown-Averting Appropriations Bill

Consolidated Appropriations Act gives FDA $5.58bn overall, 8.7% more than allocated in FY 2018. FDA received $268.8m in additional budget authority and $178.3m in additional user fee funds. FY 2019 funding would have lapsed Feb. 16 and another government shutdown would have started if President Trump didn't sign the bill on Feb. 15.

International United States
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