Preparing for the end of the Brexit transition, the U.K. Medicine and Healthcare Products Regulatory Agency issued new guidance Dec. 11 on supplying investigational medicinal products (IMPs) from Great Britain to Northern Ireland.
Taking what it calls a pragmatic approach, the MHRA said manufacturers can apply EU rules on importation requirements until Dec. 31, 2021. Qualified person (QP) certification done in Great Britain will enable supply of an IMP to Northern Ireland through 2021, as will QP certification done in the EU/European Economic Area (EEA).
However, beginning in 2022, IMPs supplied from Great Britain to Northern Ireland will require importation through a manufacture and importation authorization holder in Northern Ireland or an EEA state.
“It is important that clinical trial supply chains prepare for changes to Northern Ireland supply routes before [Jan. 1, 2022],” the MHRA said.
Health Canada to extend COVID-19 flexibilities
To ensure predictability for COVID-19 clinical trials, Health Canada has proposed extending its May interim order on clinical trials for COVID-19 drugs and devices until at least the fall of 2021. Currently, the order is set to expire May 23, 2021.
“In light of the ongoing COVID-19 pandemic, there’s a need for sponsors of clinical trials for urgent drugs and devices used to diagnose, treat, mitigate or prevent urgent drugs COVID-19 to continue their work,” Health Canada said.
The agency also is considering amendments that would set most records retention requirements to 15 years. For medical devices, it proposed aligning the records requirements with those outlined in the Medical Devices Regulations.
Neither the interim order nor the proposed transition regulations would apply to radiopharmaceutical drugs and Class I medical devices.
USTR seeking input on nations with poor IP protections
The Office of the U.S. Trade Representative (USTR) is seeking feedback on its annual review of nations that deny adequate and effective protection of intellectual property, including patents, to determine which nations should be placed on a watch list.
Section 182 of the Trade Act of 1974, commonly known as the Special 301 provisions, gives the USTR the authority to publish a list of non-U.S. governments that fail to provide adequate intellectual property protections via a watch list and a priority watch list.
The USTR ordinarily draws comments related to the Special 301 provisions in person, but it will take written comments for the 2021 report due to the COVID-19 pandemic. The deadline for written comments is Jan. 28, while foreign governments have until Feb. 11, to comment.
The USTR will publish the 2021 edition of the Special 301 report on or about April 30. Comments should be submitted at regulations.gov under docket number USTR-2020-0041.