In this week’s news, IPO wants input on SPC waiver plan, US FDA updated on GDUFA 2, EMA urges pharma to use patient registries and more…
UK IP authorities say SPC waiver will need amending due to Brexit
The UK Intellectual Property Office wants CDMO feedback on plan to make sure the EU SPC waiver works after Brexit.
The IPO called for feedback on draft legislation last week, explaining its aim is to “fix various provisions relating to this manufacturing waiver which will no longer function correctly after the UK leaves the EU.”
Supplementary protection certificates (SPC) are additional patent protection periods granted to innovator pharmaceutical firms to compensate them for time lost while the EMA was reviewing their drugs.
The SPC waiver – which was approved by the European Parliament in April – removes barriers that stopped EU-based CDMOs making drugs and APIs for non-EU markets while the SPCs were in place.
When the UK withdraws from the EU the SPC Regulation that exists on exit day will be retained automatically as UK domestic law.
The problem – says the IPO – is that “there will be parts of the SPC Regulation which are introduced by the waiver Regulation, and kept by the Withdrawal Act, that will not work correctly.”
It cited references in the legislation about manufacturing taking place “in the Union” explaining its draft legislation is designed to make clear that production in the UK will be allowed for export, stockpiling of local use.
Read the full draft legislation here.
OGD shares details of research conducted under GDUFA II
The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) has shared details of research conducted during GDUFA II.
GDUFA II – or the generic drug user fees act – is a law designed to speed access to safe, effective generics and reduce industry costs. GDUFA II, the second iteration of the law, was signed into law in 2017.
Since then the OGD has been busy.
According to a report last week, the office created 136 new product-specific guidances (PSGs) to help generic drug firms in 2018. It also received 83 pre-abbreviated new drug application (ANDA) meeting requests for complex generics in the period.
See the full report here.
Patients are a virtue: EMA
The EMA says patient registries may help drive drug innovation.
The Amsterdam-based regulator made the comments in a research paper published last week.
Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time.
According to the authors these registries are an untapped resource when it comes to drug development.
They wrote that “patient registries are potentially valuable sources of data for supporting regulatory decision-making, especially for products to treat rare diseases.
Despite this the researchers say “registries are greatly underused in regulatory assessments,” citing heterogeneity in design and in the data as well as unreliable data quality as the key barriers..
The also suggested efforts like the EMA’s Patient Registries Initiative are a step in the right direction.
Also in the news
Pharma is still winning – on drug prices and lobbying – according to STAT.
The UK Government has shared more details of the MHRA’s activities during 2018. Brexit preparations have accelerated.
Reuters reported Canadian concerns about US plans to import more drugs from the country. Shortages are a major worry.
And finally some developments of note in the CDMO space:
Lubrizol has acquired Bavaria Medizin Technologie GmbH (BMT), a designer and manufacturer of intravascular and nonvascular devices. Lubrizol said BMT’s experience in the drug-coated balloon (DCB) space aligns with its CDMO business.
IDT Biologika has inaugurated a vaccine production facility at the BioPharmaPark in Dessau-Rosslau, Germany. The firm cited the “dynamic growth” of its human vaccines business as the driver for the investment.
Lonza has hired Rockwell Automation to kit out facilities bought when it acquired Capsugel with digital technologies. The deal is part of the Swiss firm’s efforts to digitize its manufacturing operations.