In this week’s news, PIC/S preps GMP deviation guide, Scotland’s pharma boom, US FDA okays 23andMe test for genes that cut drug efficacy and more…
International body to publish GMP deficiencies guide for regulators and industry
The PIC/S has developed guidelines to help regulators classify deficiencies at drug manufacturing plants in a more uniform way.
The organisation, which focuses on improving collaboration between regulators in different countries, announced the guidelines at a meeting in Chicago last week (click here for pdf).
It said the guidelines, which come into force in January, are a tool to support “the risk based classification of GMP deficiencies from inspections and to ensure greater consistency amongst inspectorates.”
The aim is to provide information on the principles used to classify GMP deficiencies during drug manufacturing facility inspections and also to provide examples.
The organisation will publish the guidelines here in the next few months.
EU inspectors find drug plant problems in India, Italy and Spain
In related news, more GMP deficiencies were reported this week with various European regulators issuing letters of non-compliance to drug firms in India, Italy and Spain.
According to documents posted on EudraGMDP, inspectors found problems at plants operated by Genfarma Laboratorio, Biomedica Foscama Group and Mercury Laboratories.
For full details see RAPS.
Pharma looking bonny in Scotland
Scotland’s drug industry generated nearly £500m in exports last year and clinical trials worth some £40m are being conducted in the country according to the ABPI.
The UK drug industry group shared details of Scotland’s “booming” pharma industry last week, also disclosing that international drug firms spend £120m on R&D in the country each year.
The report cites the opening of a new GSK plant as well as recently announced plans for the Medicines Manufacturing Innovation Centre (MMIC) in Renfrewshire as evidence of the Scottish drug industry’s growth.
Alison Culpan, Director of ABPI Scotland, said: “Scotland is internationally renowned for our legacy of scientific excellence, having fostered great scientists and given rise to world-changing breakthroughs. Ours is a sector Scotland can be proud of.
Culpan also touched on Brexit. She explained that “it’s more important than ever for the Scottish Government to be ambitious, working in collaboration with ABPI Scotland, our members and the wider Life Sciences community, to secure an environment for our industry to flourish, ultimately reaping rewards for patients and our economy.”
UK MPs worried half of clinical trials do not publish results
The UK’s Science and Technology Committee is worried that nearly half of clinical trials fail to publish results.
The Parliamentary Committee raised its concerns last week, arguing that current rules and publication guidelines are not sufficient. Instead, the committee said the UK should adhere to soon-to-be-introduced EU trial transparency regulations.
“The Government should explicitly commit to introducing the clinical trials transparency requirements in the EU Clinical Trials Regulation that are expected to be applied in the EU shortly after Brexit.”
Interestingly the committee was positive about efforts made by drug firms to improve trial reporting practices. Instead, its concerns focused on the lack of publication by academic institutions and publicly funded organisations.
Also in the news
The UK Bioindustry Association (BIA) looked at what the latest UK budget means for the Pharma sector. Topics covered include NHS funding and Brexit preparations.
The BIA also assessed the chancellor’s plan to “unlock patient capital” by relaxing laws that have hitherto prevented defined contribution (DC) pension funds from investing in high risk companies, including biotech start-ups.
Read more at the FT.
The US FDA authorised the 23andMe Personal Genome Service to provide a direct-to-consumer test for genetic variants that may be associated with a patient’s ability to metabolize some medications.
The authorisation includes a number of “special controls,” including the requirement that the test be labelled with a warning “that the consumer should not use the test results to stop or change any medication.”
Pharmaphorum reported that Bayer is using AI to help it meet its pharmacovigilance obligations.
Drones will be used to deliver vaccine to remote settlements on the Pacific island Vanuatu according to the Guardian.
US Politicians want manufacturers to reduce the price of insulin.
STAT reported that a bipartisan group wants to introduce measures to force firms to cut the price of the product, including the requirement that they disclose production costs.
In related news, Pfizer has hinted it is likely to resume price increases next year according to Biocentury.
The publication said CEO Ian Read’s statement the firm would return to “business as normal” suggests Pfizer does not expect the Trump administration to implement its drug pricing blueprint by year end. Here’s a similar take from Evaluate.