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...

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...

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...

Proposed legislation from the European Commission (EC) would “irretrievably sabotage” the pharmaceutical industry and “send Europe to the back of the queue for healthcare treatments, clinical research, jobs and global investment.”   That’s the reaction of the European Federation of Pharmaceutical Industries and Association (EFPIA) to a leaked draft of proposed EC pharmaceutical legislation.   “Whether it is naivety, blind optimism or a more conscious decision for E...

The Drug Regulatory Authority of Pakistan (DRAP) has finalized its first set of consolidated guidelines on good manufacturing practices (GMP), overhauling a section on quality control since releasing a draft document last month.   While most of the final document remains unchanged from the earlier draft, DRAP made extensive revisions to the quality control requirements, rewriting and expanding its original stance and bringing its GMP rules into one document for the f...

EFPIA has voiced support for the European Commission’s proposed reforms of the rules on regulatory fees and charges. However, while the trade group is aligned with the Commission on most key points, it raised fears that changes to the remuneration for scientific advice may have unintended consequences.   In December, the Commission set out plans to simplify the legislation governing the fees the European Medicines Agency (EMA) charges drug and medical device companie...

Australia’s Therapeutic Goods Administration (TGA) is set to reclassify the psychoactive substances MDMA and psilocybin to enable authorized psychiatrists to prescribe them for the treatment of certain mental health conditions. The ruling overturns the interim decision that officials reached last year.   The new rules, which take effect on 1 July, permit the prescribing of MDMA for the treatment of post-traumatic stress disorder and psilocybin for use in people with tr...