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Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

Biocon, Dr Reddy’s Might Be Out Of The Woods On GMP Issue

Two Indian firms – Biocon and Dr Reddy’s – have received crucial establishment inspection reports (EIRs) from the US FDA amid improved compliance levels at their manufacturing sites.

Manufacturing Compliance

Global Pharma Guidance Tracker – October 2017

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

Australia Hong Kong

EU, US, Japan Further Align Clinical Trial Requirements For Certain New Antibiotics

To support the development of antibiotics, regulators from the EU, the US and Japan met for the third time in two years and agreed to further align their clinical trial requirements to study the effects of new drugs in certain indications. The initiative was launched in response to increasing global concerns over antimicrobial resistance and the lack of development of new antibiotics.

Clinical Trials Regulation

Risk Assessments Of New Drug Elemental Impurities Get Mixed Reviews From Regulators

ICH Q3D went into effect in June 2016 for new drugs, but so far doesn't seem to have completely resolved worries about the presence of elemental impurities in drug products.

Manufacturing Quality

PTC Readies China Plan Amid US FDA Translarna Setback

PTC is engaging physicians and Duchenne muscular dystrophy patients in China to access a largely untapped market but regulatory and reimbursement-related uncertainties could pose challenges.

Clinical Trials Rare Diseases

Lost In Translation: Rx Drug Used Where OTC Hydrocortisone Belongs

In a "translation mistake," Zhanjiang Jimin Pharmaceutical's management "thought hydrocortisone was the same material as dexamethasone," FDA says. The China firm's product, distributed in the US by Lucky Mart Inc. under the brand Piyanping Anti-Itch Lotion, is being recalled.

China International
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Europe

Set Alert for Europe

Latest From Europe

Biocon, Dr Reddy’s Might Be Out Of The Woods On GMP Issue

Two Indian firms – Biocon and Dr Reddy’s – have received crucial establishment inspection reports (EIRs) from the US FDA amid improved compliance levels at their manufacturing sites.

Manufacturing Compliance

EMA Recommends New Approaches To Characterize Toxicity Of Anticancer Drugs

The European Medicines Agency has outlined new approaches for collecting and reporting of safety data to help better understand the toxicity and tolerability profiles of anticancer medicines. The new recommendations are published in an updated guideline that will apply from April 2018.

Safety Regulation

Will HTA Bodies Accept Your Innovative Trial Design?

Innovative trial designs add a new layer of uncertainty for health technology appraisal bodies. They are likely to adapt to a changing environment, but there could be a price for companies.

Clinical Trials Drug Approval Standards

European Commission Finally Delivers On GMP Standards For ATMPs

Following protracted consultations with stakeholders on how best to specify good manufacturing practice standards for advanced therapies, the European Commission has at last published the long-awaited guideline. The industry is now keen to work with EU inspectors and competent authorities to develop a common understanding of the risk-based principles outlined in the final document.

Manufacturing Europe

Medicines In The Environment: EU Moots Action On ‘Green’ Manufacturing, Pack Sizes, Discharges

Stakeholders in the EU are being asked to give their views on ways of addressing the problem of pharmaceuticals posing public health risks when they enter the environment via their manufacture, use and disposal. “Green” manufacturing and design, closer monitoring of discharges and more appropriate pack sizes are among proposals put forward.

Compliance Europe

Pharma Faces More Probes On Generic Price Hikes in UK

As Concordia finds itself in the dock again, this time over its pricing of the essential thyroid treatment liothyronine, the UK's Competition and Markets Authority has recently opened four new investigations into "suspected abuse of dominance" concerning generics.

Legal Issues Pricing Strategies
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United States

Set Alert for United States

Latest From United States

No More 'Hidden' Facilities, US FDA Tells Generic Sponsors

Agency officials don't care if DMF holder doesn't give access to its entire facility list; FDA says industry is responsible for listing all facilities that could be used as part of ANDA.

Generic Drugs Review Pathway

FTC Scrutiny Of Profit Seeking In Drug Supply Chain In Fact-Finding Mode

Agency hears from experts on whether PBMs and group purchasing organizations operate under misaligned incentives.

Pricing Debate Legal Issues

US FDA Staff Slams Agency Hiring Policies In Report Ahead Of Public Meeting

Agency to discuss results of report, as well as pending 2018 pilot project designed to modernize its hiring practices.

FDA Leadership

Alex Azar And The Return Of Republican-Style Price Negotiation

The nomination of a former drug industry executive to run HHS is obviously good news for the biopharma sector, but it does not mean that HHS will do nothing about drug prices. On the contrary, it may make some high-profile action against pricing outliers all but inevitable.

Pricing Debate Policy

FDA's NDA And BLA Approvals: Juluca

Original new drugs and biologics recently approved by US FDA.
Approvals Regulation

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review
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