In this week’s news, US FDA over reliant on foreign APIs, raft of new US guidance documents, Health Canada sets up devices unit and more…
CDER wants to reduce US reliance on overseas-made APIs
US reliance on foreign-made drug ingredients continues to be a security risk according to CDER director Janet Woodcock, who says FDA efforts to encourage use of locally made APIs are ongoing.
Woodcock made the comments to coincide with release of data indicating 72% of the API firms that supply the US are based outside the county. Some 13% of the ingredients used in drugs in the US are made in China.
She wrote, “The increasing number of API manufacturing sites in China and other countries suggests that the United States’ reliance on Chinese and other foreign sources of API is growing.
She added that the FDA has been working with industry and other federal agencies to ensure our reliance of foreign manufacturing does not pose a national security risk.
“While FDA cannot tell industry where they can and cannot manufacture APIs, we can work with industry to utilise new technologies and new manufacturing methods to further incentivise domestic production of drugs and APIs. These new ways of making drugs could, with the proper strategies, revitalise pharmaceutical manufacturing in the United States.
See the full report here.
US FDA draft guidelines on transdermal meds and 105 drug-specific guidance docs
The US FDA has published draft guidelines for firms working with topical and transdermal delivery systems.
The document – available here – makes clear that drugs that use transdermal delivery systems (TDS) are considered combination products under US regulations.
In other news, the agency has published 105 drug-specific guidance documents. For full details visit RAPS.
Biologics driving CDMO boom
The CDMO sector is growing at its fastest rate since 2012 according to research by GlobalData.
The research suggests the total value of the contracting market grew 6.4% in 2018. The analysts attribute the surge to growing demand for biologics manufacturing services.
Lead analysts Adam Bradbury told European Pharmaceutical Review that, “As drug production becomes increasingly complex from a molecular and regulatory standpoint, innovative CMOs stand to prosper.”
“This is especially true as the drugs pipeline favours the development of high potency active pharmaceutical ingredients (APIs) for oncology, where the facilities, expertise and equipment related to their manufacture are prohibitively expensive for smaller pharma companies.”
Health Canada sets up medical devices directorate
Health Canada has established a new unit to work with the medical device industry.
According to a letter published last week the directorate is designed to respond to the challenges and opportunities related to the medical device industry.
Health Canada has created 165 positions and given the directorate a budget of $15.85 million.
EMA’s Brexit costs surge
Preparations for the UK’s withdrawal from the EU have cost €60m in 2019 according to the EMA.
The Amsterdam regulator announced its Brexit related costs last week, explaining the €59.6 million spent this year is a marked increase on the €15.5 million it shelled out in 2018.
Also in the news
Fake pharmaceuticals continue to be a huge drain on economic resources according to a report by the Medicine Maker. Drug companies trying to protect products against counterfeiters face increasing costs.
A Wall Street Journal report suggests not enough generic pharmaceutical products are coming to market. The author says patient access to medicines continues to be restricted.
RAPS covered the release of US FDA guidance on how drug companies can obtain certificates of confidentiality. The aim of such documents is to prevent researchers from being compelled to disclose identifiable, sensitive information about research participants.
Some developments of note in the contract manufacturing space.
Beigenes has hired Catalent to make Brukinsa (zanubrutinib), a treatment for mantle cell carcinoma that was recently approved by the US FDA.
PDMA inspectors have cleared Metrics Contract Services’ Greenville North Carolina facility to manufacture cancer drugs for the Japanese market.
Wuxi Bio has welcomed clinical progress made by Tychan’s yellow fever treatment candidate, TY014.
Sweden based contractor Recipharm has announced it will buy Consort Medical for £505 million.