In this week’s news, regulator collaborations coming, Device industry concerns about NB capacity, FDA plans ANDA withdrawals and more…
2020: the year of regulatory collaboration
Drug regulators in different markets will share more inspection data and resources in 2020 according to various reports.
Recently, Swissmedic, the Swiss Agency for Therapeutic Products, and the equivalent authority in the Republic of Korea agreed to work more closely in the therapeutic products sector.
The deal – which will allow the agencies’ to rely on each other’s GMP inspection results – is designed to facilitate the bilateral trade in medicinal products between Switzerland and Korea and reduce the regulators workload.
And the collaboration will not be the last. According to a report by Pharmaintelligence mutual recognition deals are a top priority for the Pharmaceutical Inspection Co-operation Scheme (PIC/S) this year.
Med device firms worried about oversight capacity in Europe
The medical device sector is concerns about a lack of notified body capacity in Europe in the three years since the Medical Device Regulation (MDR) came into force.
Last week industry group MedTech Europe shared its concerns about notified bodies and other issues facing the industry in a call to action.
In the EU member states designate a notified body to assess the conformity of certain products with the applicable essential technical requirements.
According to MedTech Europe “The MDR transition period is nearly over, however, the new regulatory system is not yet ready to support the transition of tens of thousands of lifesaving and life-transforming technologies from the old regulatory regime to the new.”
See the full call to action document here.
US FDA plans ANDA crackdown
The US FDA wants to withdraw the approval of 249 abbreviated new drug applications (ANDAs) because holders have failed to file annual reports.
According to a post in the Federal Register “The basis for the proposal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs.”
Generics companies will be given the opportunity to “request a hearing on this proposal” the agency said.
Also in the news
The New York Times turned its spotlight on the development and production of antibiotics. According to the paper the recent failure of a number of companies does not bode well for the future of anti-infectives.
The annual JP Morgan healthcare conferences kicks off this week. Thousands of drug industry deal makers are in San Francisco to make the investments that will shape the pharmaceutical industry over the next 12 months. To celebrate STAT took a look at the last 20 years of the event.
PWC has forecast continued growth for the CDMO sector. The firm made the suggestions in a detailed report on the third-party manufacturing industry. See full report here.
And finally, some developments of note in the contract manufacturing sector:
Alcami has sold its API manufacturing facility in Weert, the Netherlands to CDMO MerachemSyncom.
Catalent has bought a fill finish plant for biologics in Anagni, Italy. The facility was previously owned by Bristol Myers-Squibb.
Wuxi STA has opened a large-scale manufacturing facility for the production of oligonucleotides in Changzhou, China.