The Medicines and Healthcare products Regulatory Agency (MHRA) has committed to embarking on the UK’s “biggest overhaul of trial regulation in 20 years” after a consultation revealed support for many of the draft proposals.   At the start of 2022, MHRA sought feedback on proposals to take advantage of the UK’s split with the EU and “deliver a world-class sovereign regulatory environment for clinical trials.”  The goals of the proposed legislative amendments included st...

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has set out the safety control measures it plans to implement in response to the launch of generic versions of Bristol Myers Squibb’s blood cancer drug Revlimid (lenalidomide).   The dispensing of lenalidomide Japan is covered by the RevMate control procedures because the drug molecule has a similar chemical structure to thalidomide and was shown to cause birth defects and abnormalities in animal studies. Japan’...

The European Commission has published delegated regulations to change the frequency that notified bodies are reassessed under the new device and diagnostic regulations.   Under the original Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), notified bodies designated to certify devices under the rules needed to be reassessed three years after first being notified and every four years thereafter. The need to free up time at existing MDR/IVDR no...

The Therapeutic Goods Administration (TGA) has fined the Australian pharmaceutical company Contract Manufacturing & Packaging Services (CMPS) AU$159,840 ($106,463) for allegedly breaching the terms of its license.   CMPS’ website states that it “manufactures pharmaceuticals under the strictest quality standards and complies with international manufacturing and health requirements of PIC/S countries.” Working out of a site in Sydney, the company makes complex formulat...

Regulatory Focus is pleased to announce a new biweekly Latin America Roundup focused on regulatory issues in Latin America and the Caribbean. If you have any tips or stories we missed, please send them to news@raps.org .   A frequent post-pandemic theme among Latin American agencies has been coordination and harmonization among regional regulators.   Earlier this year the Mexican government formally backed the creation of a Latin American Medicines Agency, a pan...

A group formed to advise the UK government on the regulation of medical devices is pushing for officials to “rapidly explore” building an equivalence route for approvals to include jurisdictions such as the US.   Last year, members of the UK Life Sciences Council, which brings together government, regulators and industry, formed an advisory group to create recommendations on the reform of medtech regulation. With the UK leaving the European Union, the Council saw a “go...

The Philippine Food and Drug Administration (FDA) has posted guidelines about relying on the decisions of other regulatory agencies to facilitate the evaluation of clinical trial applications.   FDA, which has moved to increase regulatory reliance in multiple areas in recent years, pitched the new guidance to improve access to investigational drug products for public health emergencies, rare diseases and “emerging and re-emerging infectious diseases of public health th...

Regulation of human medicines in Northern Ireland now are the responsibility of the UK Medicines and Healthcare products Regulatory Agency (MRHA) under an changes to the Brexit agreement finalized by the UK and the EU.   Northern Ireland occupied a unique position under original Brexit agreement. While the region remained part of the UK, the European Medicines Agency (EMA) became responsible for human medicines, creating a situation in which a medicine was available in...

The Drug Regulatory Authority of Pakistan (DRAP) is urgently recalling seven products manufactured by Davis Pharmaceutical Laboratories because of the discovery of ethylene glycol at “unacceptable levels.”   Earlier this month, Gambia’s Medical Control Agency issued a safety alert about a batch of KOF Relief Syrup, a product that contains a combination of ingredients designed to relieve dry coughs and other cold symptoms. Gambia, where tens of children died last year a...

Regulatory Focus is pleased to announce a new biweekly Latin America Roundup focused on regulatory issues in Latin America and the Caribbean. If you have any tips or stories we missed, please send them to news@raps.org . Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) hosted a meeting in February with officials from the US FDA, including Katherine Serrano, the agency’s Latin America director. The focus of the meeting was increasing coll...

Against a backdrop of falling investment in commercial clinical trials, the UK government will undertake an independent review under Lord James O’Shaughnessy to find and clear potential barriers.   Data collated by pharma trade group ABPI show the number of industry clinical trials initiated in the UK has fallen each year since 2017, the year after the vote to leave the European Union. The steepest fall in activity happened during the pandemic years. By 2021, the num...

Australia’s Therapeutic Goods Administration (TGA) has proposed double-digit increases to its annual charges to cover inflation and recoup investment in its digital transformation and move to purpose-built facilities.   In a public consultation, TGA has outlined plans to apply a 5.2% indexation factor to fees and charges to cover most of its rising costs — inflation in Australia is 7% — while still incentivizing the agency to find savings and efficiencies. However, the...