In this week’s news, China rolls out rules for CDMOs, FDA launches interchangeability guidelines and more…
China provides model quality agreement for CDMOs
China has issued new guidelines on contract pharmaceutical manufacturing that include advice on quality agreements.
According to analysis by law firm Reed Smith, the guidelines also sets forth the regulatory aspects of contract drug manufacturing that the National Medical Products Administration (NMPA) will focus on in its audits and inspections.
According to the authors, “It is highly recommended that the MAH, who is legally required to take primary responsibility, negotiates in detail and conducts a thorough review of the quality agreement with the potential manufacturer before entering into the contract manufacturing arrangement.”
UK and EU agree to phase-in post Brexit pharma regs in Northern Ireland by 2021
The UK Government has outlined a phased process for medicines and drug manufacturing regulations in Northern Ireland.
According to a statement last week, the UK and EU agreed a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021.
The Government said the aim is to provide “the additional time needed for businesses to prepare in relation to batch testing, importation and Falsified Medicines Directive requirements.
The process will also provide time for transit procedures for APIs and pharmaceutical to be available in Northern Ireland and operate consistently with the Common Transit Convention.
Amazon launches online pharmacy service
US tech giant Amazon has set up an online pharmacy that will deliver prescription drugs in the US.
The new service will offer discounts of up to 80 per cent on generic drugs for Prime subscribers.
Amazon entered the drug space in 2018 when it bought Pillpack, a mail-order pharmacy that packages and delivers medicines by post.
The firm has not disclosed how it will source the medicines it sells.
Also in the news
The Wall Street Journal reported on Corning’s efforts to develop glass vial technology for SARS-CoV-2 vaccines.
Pfizer and Moderna are due to request emergency use authorisation (EUA) for the candidate SARS-CoV-2 vaccines according to RAPS.
The EMA has set a 50% efficacy goal for trials of candidate coronavirus vaccines.
The US FDA has released draft guidance on biosimilar “interchangeability” to help developers ensure their products are a match for originator biologics.
FDA news reported efforts to set up a biopharmaceutical manufacturing centre in Africa. Read more here (subscription).
EU pharmaceutical supply chains are still vulnerable to the pandemic according to a report in the European Pharmaceutical Review.
Some developments of note in the contracting space:
Catalent has shrugged off recent setbacks in the gene therapy sector and says the market will be a revenue generator going forward.
Cambrex will spend more than $50m to expand capacity at its API production facility in Charles City, Iowa.
Eli Lilly has hired Samsung Biologics to help develop and manufacture its Covid-19 antibody therapies.
Wuxi Biologics has opened a biologics innovation centre in Hangzhou, China.
The US International Development Finance Corporation (DFC) has loaned ApiJect Systems $590 million loan to construct a manufacturing campus to package injectable medicines