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Global

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ICH Makes Progress On Tackling Safety Data ‘Overload’

Changes to an ICH guideline could help drug companies that are being deluged with post-approval safety information to cut down on noisy, low-value data.

Safety International

Coronavirus Notebook: Molnupiravir EU Approval Likely By Year End, Special CHMP Session Due On Comirnaty in 5 to 11-year-olds

The EMA is assessing the Janssen vaccine as a booster, and Switzerland is evaluating the use of the Pfizer/BioNTech and Moderna COVID-19 vaccines in younger age groups. The WHO has announced the first voluntary global license on a COVID-19 antibody detection technology.

Europe Switzerland

Voluntary Limits On Antibacterial Discharges Increase As Fear Of Resistance Grows

Pharmaceutical companies are ratcheting up voluntary efforts to control discharges of antimicrobials from their plants and those of their active pharmaceutical ingredient suppliers so they won’t contribute to antimicrobial resistance. But will it be enough to fend off regulation in countries like India?

Manufacturing Compliance

Pfizer & MPP Sign Deal For Generics Of COVID-19 Candidate Paxlovid

An agreement allowing the production and distribution of the US firm’s new protease inhibitor in 95 countries has been welcomed by the Medicines Patent Pool. But some medicines access advocates are not so sure it’s necessarily a good deal for lower-income countries.

International Coronavirus COVID-19

Generics Firms Seek To Establish Better Conditions For Post-Approval Change Flexibility

Concerns raised around defining ICH Q12 “established conditions” for post-approval changes and potential role of prior knowledge for legacy products discussed in the context of generic drug applications; likely residual lack of harmonization explored.

Manufacturing Quality

The Real Story Behind COVID-19 Vaccine Safety Monitoring

A senior AstraZeneca executive gives a candid account of how the company recovered from the unexpected deluge of safety reports for its COVID-19 vaccine.

Coronavirus COVID-19 Vaccines

Coronavirus Notebook: WHO OKs Bharat’s Covaxin, AZ Pulls Swiss Vaxzevria Filing

The US FDA has rejected an emergency use authorization application for NRx Pharmaceuticals’ Zyesami (aviptadil) for use in COVID-19 patients with respiratory failure. The UK has revamped its emergency delivery service for drugs that experience shortages as a result of the pandemic and other factors.

International United Kingdom

Global Pharma Guidance Tracker – October 2021

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation

Global Industry Bodies Urge Wider Use Of COVID-19-Related Regulatory Flexibilities

A range of steps have been taken to allow the scale-up of manufacturing of COVID-19 products during the pandemic. Now industry says the use of these flexibilities needs to be expanded to enhance the current pandemic response and rapidly increase product supply.

Europe International

Merck’s Molnupiravir Open License With Medicines Patent Pool May Be Model

Pharma industry critics herald the agreement for allowing many manufacturers around the world to make the COVID-19 therapeutic and for its transparency. If Merck can do it, they ask, why can’t other companies?

Coronavirus COVID-19 Intellectual Property

Continuous Manufacturing Guidance From US FDA Aims For Wider Industry Adoption

Draft tracks ICH document, which touts the ‘efficiency, agility, and flexibility’ of continuous manufacturing while acknowledging the challenges around the developing practice, ‘particularly for products intended for commercialization internationally.’

Manufacturing Guidance Documents

ICH Emphasizes Need For Quality In Clinical Trials

The International Council for Harmonisation has delivered the first of a two-part project to modernize the international good clinical practice framework by finalizing changes to its primary efficacy guideline. 

Clinical Trials Regulation
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