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Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

Pharma’s ‘No-Show’ At Regulatory Meetings In India: Who Loses?

Regulators in India routinely face flak over lengthy approval timelines, but drug firms failing to show up at pre-scheduled regulatory meetings does little to improve the situation. The reason for the no-shows is open to speculation. Absenteeism appears to be significant in areas such as oncology and hematology.

Regulation Review Pathway

Australian Black Triangle Scheme To Start in 2018

From next year drug manufacturers operating in Australia will have to start placing a black triangle symbol on the product information and consumer medicines information documents for certain newly approved prescription products and new indications.

Australia Drug Safety

China Innovation Policy Reform Streamlines Trial Management

China's latest initiative to establish an innovation ecosystem replaces clinical trial site pre-certification with registration; also included are provisions allowing use of foreign data, strengthening data protection and providing conditional approvals of rare disease treatments.

China Clinical Trials

Australia Moves Forward With Biovigilance Guidelines

Australia’s regulator has responded to consultation submissions and is moving forward with plans to issue guidance on biovigilance.

Australia Biologics

Korea’s Biotech Roadmap Aims To Bridge Funding Gaps

South Korea reaffirms its supportive policy stance for the biotech industry with a new long-term roadmap. The plan covers the entire cycle of drug development, including R&D support to tackle the industry’s ‘valley of death’ and creation of a mega fund to help companies enter global markets.

Research & Development South Korea

Global Pharma Guidance Tracker – September 2017

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.

Regulation BioPharmaceutical
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Set Alert for Europe

Latest From Europe

Consultation To Help Determine Whether EU SPC Framework Fit For Purpose

The European Commission has launched a consultation on proposals to “recalibrate” supplementary protection certificates and patent research exemptions.

Europe Biosimilars

EU ‘Vaccine Hesitancy’ And Why It’s A Problem For Manufacturers And Public Health

“Vaccine hesitancy” – the gradual decline in rates of vaccination against preventable diseases – has led to outbreaks of illnesses such as measles in several European countries, fueled by factors such as complacency and lack of trust or access to vaccines. Ian Schofield spoke to Patricia Massetti, associate vice-president and European vaccines lead at MSD, and Andrea Ammon, the new director of the ECDC, about the implications of vaccine hesitancy, including what can be done to counter it, and the difficulty of planning vaccine manufacture for predicted future outbreaks.

Vaccines Europe

European CHMP Opinions And MAA Updates

A monthly-updated listing of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Approvals Performance Tracker

Delay Means New EU Clinical Trial Rules May Not Be Transferred To UK

With the implementation of the EU Clinical Trials Regulation now postponed to the second half of 2019, it is unlikely that its provisions will be taken over into UK legislation as part of the Brexit “Repeal Bill” that will convert all EU laws and regulations into domestic UK law.

Clinical Trials Brexit

The Tricky Business Of Balancing Public Health Interests With Timely Authorization Of Generics

Efforts by regulators to avoid unnecessary non-clinical and clinical testing are welcome, but it is important to ensure that any new methods used to establish therapeutic equivalence are based on robust scientific data, says lawyer Lincoln Tsang.

Europe Clinical Trials

PDA Survey Shows Compliance Can Trump Science In Aseptic Processing

PDA leaders weigh in on results of recent aseptic practices survey, saying pharmaceutical manufacturers may be carrying out certain aseptic practices to meet the expectations of regulators rather than the dictates of science. The survey also shows that despite adoption of technologies like RABS and isolators to keep workers away from sterile drug products, half the time they're still the root cause of contamination.

Europe United States
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United States

Set Alert for United States

Latest From United States

A Big Week For FDA’s Top Eye Drug Reviewer

Ophthalmology supervisory medical officer Wiley Chambers played a key role at three different advisory committee meetings in early October. Only one was a review in his division.

Advisory Committees Drug Review

Combo Product Classification Guidance Doesn't Fix All Existing Problems, Experts Say

US FDA's tendency to designate products as drugs over devices may remain despite clarifications offered in final guidance.

Review Pathway FDA

FDA Search For CDER Deputy Emphasizes 'Executive Direction'

An M.D. is preferred for position that would run CDER in director's absence and oversee 'major programs' at the Center.

FDA Leadership

Moscicki's Move From FDA To PhRMA About 'Best' Use Of Leadership Skills

At inconveniently timed NORD conference, the former CDER deputy center director finds himself unable to speak for either FDA or the Pharmaceutical Research and Manufacturers of America.

FDA Leadership

Anthem In-House PBM Will Draw On CVS But Retain Formulary Control

Hybrid approach to pharmacy benefit management expected to save insurer $4bn annually after Anthem ends its relationship with Express Scripts in 2020. Integration of medical and Rx benefit data could lead to more value-based contracting.

Pharmacy Benefit Management Pricing Strategies

Semaglutide Retinopathy Risk No Bar To Approval, US Panel Says

Novo Nordisk's once-weekly GLP-1 agonist can address diabetic retinopathy complications through labeling, US FDA advisory committee says in endorsing approval; panelists say a postmarketing study on retinopathy would be desirable and could be folded into a larger cardiovascular outcomes trial.

Advisory Committees Drug Review
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