In this week’s news, EU passes SPC waiver, industry calls for quality standards alignment, China mulls new regulations, US may accept shorter IP for biologics in China talks and more…
European Parliament passes SPC manufacturing waiver
The European Parliament has given generics firms and CDMOs the greenlight to start making versions of drugs and APIs covered by SPCs while the certificates are in place.
The decision – which was reported by Lexology – came on April 17 when parliamentarians approved an amendment of the Regulation 469/2009 on Supplementary Protection Certificates (SPCs) to include a manufacturing waiver.
The regulation – which will come into force 20 days after details are published in the Official Journal of the European Union – removes barriers that stopped CDMOs and generics firms making drugs and APIs while SPCs were in place.
The vote was welcomed by generics industry group Medicines for Europe. Director General Adrian van den Hoven said the decision “reflects the EU’s commitment to access to medicines, manufacturing jobs in Europe and putting EU industry on a level playing field globally.
“Europe has everything to gain from fully implementing the waiver to enable more competition on the pharmaceutical market and to improve its own security of medicines supply.”
The branded drug industry has previously raised concerns about the SPC waiver. EFPIA for example has previously spoken about limiting the negative impact of the waiver of future R&D investment. Read more here.
Industry wants regulatory consensus on voluntary quality standards
Experts say international consensus on drug quality standards would be of benefit to the pharmaceutical industry.
The call came in responses to US FDA’s proposed guidelines on voluntary consensus standards (VCS), which are metrics to be agreed with industry the agency would use to evaluate various drug characteristics.
According to RAPS “by leveraging VCSs, CDER aims to promote innovation in pharmaceutical development and manufacturing while also streamlining the process for compiling and assessing marketing applications.”
In its response, The American National Standards Institute (ANSI) said the draft guidance was “a positive step” toward greater innovation and reduced burden on sponsors and CDER reviewers.
The Standards Coordinating Body (SCB) said “By referring to standards that have been harmonized internationally, CDER and industry can facilitate the elimination of barriers to trade.”
Read the full article here.
China considering new manufacturing standards
The Chinese government is mulling new drug production and development rules according to state media agency Xinhua.
The measures – proposed at the recent session of the Standing Committee of the National People’s Congress (NPC) – cover everything from responsibility for trials through to production, sale and adverse event reporting.
One of the proposals would require drug firms to sign agreements with manufacturers, sellers, transporters, etc to make sure they are capable of maintaining the quality of drugs and managing risks.
The plan would also look at drug places and ways of ensuring consistency of supplies. It would also seek to encourage research and production of drugs in short supply.
See the full story here.
US considers China concessions
In other news, the US government is considering a proposal that would give US made biopharmaceuticals sold in China just 8 years of data protection.
According to Bloomberg, the plan would mean US made drugs would get shorter protection periods in China than they do in the US or in countries covered by the proposed NAFTA agreement.
Bloomberg predicted the plan would be opposed by US biopharmaceutical firms.
Read the full story here.
Also in the news
The New York Times looked at drug companies it says are responsible for the current US opioid abuse epidemic.
Pharmaintellegince covered details of a survey suggesting pharma is finally showing more of an interest in continuous manufacturing. See more details here (subscription required).
Bioprocess Insider reported GSK is on track to restore supplies of HPV vaccine this summer.
The US FDA has raised renewed concerns about particulate contamination in injectable drugs. Read more at Pharmaintelligence.
Some developments of note in the CDMO space this week:
Catalent started work on a $14m expansion of its softgels facility in Eberbach Germany. See press release here.
Thermo Fisher Scientific shared information about the $150 million expansion of its sites in Italy and the US. The firm outlined its planned acquisition of cell and gene therapy contractor, Brammer Bio. See release here.
UK drug manufacturer GSK has invested $100 million to expand capacity at its vaccines plant in Hamilton, Montana in the US. See release here.