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UK, US & Canada Regulators Explain Why Decentralized Trials May Get A Closer Look
Decentralized clinical trials are subject to the same regulatory requirements as traditional site-based trials, but are of special interest to regulators because they represent a new way of working.
US FDA Looks To Re-Establish African Foreign Office, Add Brazil Post
As Congress pressures FDA to increase foreign inspections, the agency unveils plans to strengthen its overseas presence, including new offices and more staff in the New Delhi, India, post. Deputy Commissioner Kimberlee Trzeciak notes the moves are resource dependent.
New UAE Drug Agency Calls On Companies To Help Shape Mandate
Facilitating and strengthening R&D, intellectual property rights protection and drug safety are among the goals of the soon-to-be-launched Emirates Drug Establishment.
Global Pharma Guidance Tracker – February 2024
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.
Universal Pharmacare Makes Headway In Canada But Pharma Warns It Will Limit Access
Among the provisions in a newly tabled bill seeking to introduce a national pharmacare system in Canada is a bulk purchasing strategy for prescription drugs that could help lower costs.
For Generics, EU Reference Product Is Non-Negotiable – Even In Pilot On Parallel Advice
Acknowledging that it may be a barrier to some extent, EMA’s senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented.
Mexico Launches ‘Regulatory Certainty Strategy’ For Biosimilars
Mexico is to establish a new regulatory framework that is in line with international standards to encourage domestic production of biosimilar medicines.
Global Pharma Guidance Tracker – January 2024
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.
Canada Attacks Florida’s ‘Bad’ Bulk Importation Plan
Regulatory tools designed to prevent medicines intended for Canada being diverted elsewhere will be “crucial” for preventing shortages in the country, say Canadian authorities and industry representatives.
EMA Steps Up Support For Creation Of African Medicines Agency
The EU drugs regulator plans to provide the expertise needed to make the African Medicines Agency operational and to help develop the capabilities of the African drug regulatory network.
Regulatory Reliance Pathways: Challenges And Opportunities Ahead
International interest in fast-track regulatory reliance and collaboration pathways such as Project Orbis and the ACCESS Consortium has grown in recent years, a trend that looks set to continue in 2024. But some policy experts have warned that faster approvals are not always better, with one academic claiming the bar for marketing authorizations has dropped “far too low.”
Brazil Updates GMP Rules For Advanced Therapies
Brazil brings advanced therapy GMP regulations into line with international standards.
Drug Importation And Medicaid: Trump Era Guidance Likely Disincentivizes Use
CMS guidance on the Medicaid Drug Rebate Program, best price and drug importation from 2020 should make it less attractive for states to implement importation programs and help pharma.
South Africa & Zimbabwe Sign Deal On Joint Drug Reviews, Inspections
SAHPRA and MCAZ have signed an MoU to cooperate with each other on medicines regulation, quality control and pharmacovigilance.
Global Pharma Guidance Tracker – December 2023
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.
FDA Authorizes Florida Importation Plan, But No Drugs Cleared For Landing
The US FDA's authorization of the first ever Section 804 importation program is a notable political move, but hurdles remain before the state can import drugs and savings are expected to be minimal.
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