In this week’s news, US FDA rejigs generics rules, EMA aims to clarify on GMP, Advice for drug and device firms post Brexit, and more…
US FDA rejigs how it prioritises generic drug reviews
The US FDA has revised how it prioritises generic drug applications in a move it says will ensure fairness and best use of resources.
The US regulator outlined the changes last week, explaining “This update aims to efficiently allocate limited agency resources to areas where priority review is most likely to meaningfully increase generic drug access and ensure fairness to applicants.”
One major change is that the FDA will no longer prioritise abbreviated new drug applications (ANDAs) that contain a paragraph IV certification – which is a mechanism generics firms use to challenge patents covering branded products.
Instead the FDA “will only prioritise review of a submission if an applicant makes an explicit request for priority review, except in limited circumstances.
“Without an applicant’s explicit request for priority review, FDA will initiate priority review of an ANDA only if the drug product relates to a drug shortage; or a public health emergency; or if there are not more than three approved drugs.”
The EMA has published a reflection paper setting out marketing authorisation holders’ (MAHs) GMP responsibilities.
The paper – published last week – “seeks to provide clarity as to what the various responsibilities are and what they mean for MAHs at a practical level.”
The EMA said clarification is need because in some cases MAHs’ GMP responsibilities can “be difficult to comprehend when reading the GMP guide or the applicable legislation.”
The document covers GMP as it relates to outsourcing and technical agreements, audits and qualification activities, communication with manufacturing sites, product quality reviews, defects, complaints and recalls, supply continuity and improvement activities.
The EMA also pointed out the reflection paper should not be considered an exhaustive list and called for industry feedback.
MHRA and EMA post last minute info on Brexit
The MHRA and EMA have issued guidelines to help drug and device firms cope with the impact Brexit will have on their businesses.
The regulators issued the document on January 31, just hours before the UK formally pulled out of the EU.
First they explained EU pharmaceutical law will continue to apply to the UK until 31 December 2020, “meaning that pharmaceutical companies can continue to carry out activities until the end of the year.”
The EMA also said MAH holders have until 2021 to make changes to authorised medicines to ensure they comply with EU law and promised to publish updated guidance.
The agency stated the UK is “no longer be able to participate in EU institutions and their decision-making,” including EMA scientific meetings and working parties.
The MHRA told device firms the UK will follow EU rules, including the Medical Device Regulation which comes into effect in May, until the end of the year.
Also in the news
Biopharma is becoming more reliant on contract services firms as a result of diversification of services being offered according to a Mastercontrol blog post.
STAT suggested the novel coronavirus – 2019-nCoV – that has sickened thousands worldwide since December may impact the supply of APIs made in China.
Bioprocess Insider reported VGXI will VGXI will make Inovio Pharmaceuticals’ investigational vaccine as part of a collaborative effort to halt the progress of 2019-nCoV.
Sandoz has acquired generics manufacturer Aspen Japan K.K, a subsidiary of Aspen Pharmacare. See Sandoz statement.
RAPS reported UK efforts to clarify what will happen to supplementary protection certificates (SPCs) after the end of the Brexit transition period.
Some developments of note in the contracting space:
Piramal will invest C$25m to add API production capacity at its facility in Aurora, Canada. The plan is to expand high potency API manufacturing capabilities. See press release.
Rocket Pharmaceuticals has contracted Lonza to make trial supplies of its gene therapies for rare childhood diseases. See statement.
Wuxi Biologics established a 100+ R&D team dedicated to the development and manufacturing of multiple neutralising antibodies for 2019-nCoV. See media statement.
The university of Texas md Anderson cancer Center has acquired a cell therapy manufacturing facility from Bellicum Pharmaceuticals. See press release.