Asia-Pacific Roundup: Philippine FDA shares guidelines on regulatory reliance for the conduct of clinical trials

The Philippine Food and Drug Administration (FDA) has posted guidelines about relying on the decisions of other regulatory agencies to facilitate the evaluation of clinical trial applications.
 
FDA, which has moved to increase regulatory reliance in multiple areas in recent years, pitched the new guidance to improve access to investigational drug products for public health emergencies, rare diseases and “emerging and re-emerging infectious diseases of public health threats.” The document sets out the rules for sponsors, contract research organizations, investigators and research ethics committees that are involved in all phases of multi-region clinical trials.
 
Under the guidance, drug developers can receive clearance to run some clinical trials under the abridged regulatory pathway. The pathway enables FDA to solely or partially base its decision on the assessment of a reference drug regulatory agency (RDRAs) such as the European Medicines Agency and US Food and Drug Administration. The Philippine regulatory agency has designated 14 of its peers as RDRAs.
 
Applicants that have received approval to run a clinical trial from a RDRA and are developing a drug in one of the areas covered by the abridged regulatory pathway can request a reliance-based review when they first contact FDA. The Philippine regulator wants applicants to send “a formal letter written request” notifying it of their plans to use the abridged pathway and identifying the RDRA. FDA is asking applicants to include a copy of the clinical trial approval from the RDRA.
 
Companies that meet the criteria for the pathway will receive FDA authorization to run the clinical trial in the Philippines within 20 working days, although the process may take longer if the regulator requests clarification of any information. FDA has retained its power to reject applications.
 
Other sections of the guidelines address clinical trial protocol amendments and reporting requirements. As with initial approvals, applicants can leverage RDRA decisions on protocol amendments to accelerate the process in the Philippines. FDA aims to make decisions within 10 working days but may forward the request to the scientific advisory committee if the applicant wants to make substantial amendments, such as changes to the design and methodology, that could have a significant impact on the clinical trial.
 
Sponsors of clinical trials approved under the abridged regulatory pathway will remain subject to all the reporting requirements set out in FDA’s Regulations on the Conduct of Clinical Trials for Investigational Products. The new rules will take effect 15 calendar days after their publication.
 
FDA Guidelines
 
Malaysia’s MDA releases guidance on the notification of custom-made medical devices
 
Malaysia’s Medical Device Authority (MDA) has shared guidance on the notification process for seeking permission to import a custom-made product or place such a technology on the market.
 
MDA defines custom-made medical devices as technologies “made with a specific design characteristic in accordance with a healthcare professional’s written prescription” that are “intended to be used for a particular patient.” Under a 2016 order, custom-made medical devices are exempt from the registration requirements that apply to mass-produced technologies.
 
The new guidance describes the requirements for custom-made medical devices, their manufacturers and the written prescriptions used to request they are made available to patients. Another section of the text describes the notification process, explaining that applicants need to pay an administrative charge and that the turnaround time is 14 days from the submission of a complete form and supporting files.
 
Applicants that receive notification need to comply with certain conditions. Successful applicants are fully responsible for the importation and placement of their exempted medical devices, including supply chain activities, and must keep all information related to the product and make it available to MDA upon request. The conditions prohibit advertising to the general public.
 
MDA Guidance
 
China grants priority review to Biogen and Eisai’s Alzheimer’s disease drug lecanemab
 
China’s National Medical Products Administration (NMPA) has agreed to review a filing for approval of Biogen and Eisai’s Alzheimer’s disease therapy lecanemab under its priority pathway.
 
Eisai filed for Chinese approval of lecanemab, the anti-amyloid-beta monoclonal antibody that is already sold in the US as Leqembi, in December. The initial application contained data from a mid-phase study and the top-line results of the pivotal Clarity AD clinical trial. Per NMPA’s direction, Eisai will add more data including the full results of Clarity AD.
 
NMPA accepted lecanemab for priority review under the first of the six categories of products that can benefit from accelerated assessment. The category covers “innovative new drugs and new dosage forms for the prevention and treatment of serious infectious diseases and rare diseases for which there is an urgent clinical need.”
 
Biogen, which is co-commercializing and co-promoting the product, has experience of how the priority review pathway can accelerate market access in China. The review and approval of Spinraza, Biogen’s treatment of spinal muscular atrophy, took 173 days in China because NMPA granted it priority review and allowed the applicant to use data from overseas clinical trials.
 
Press Release
 
New Zealand’s Medsafe reports cases of pericarditis after vaccination against mpox
 
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has issued an alert after receiving two reports of pericarditis in recipients of vaccines against mpox, the virus formerly known as monkeypox.
 
Pericarditis is characterized by inflammation of the membrane around the heart. Viral infection and some vaccines, including certain products used to protect against COVID-19, are potential causes of the condition. Now, Medsafe has learnt of two cases of pericarditis that are suspected to be linked to mpox vaccination.
 
Medsafe is asking people to report suspected adverse reactions to improve its understanding of the issue and advising recipients of the vaccine to seek urgent medical attention if they develop signs of the heart condition. Pericarditis is treatable and outcomes are best when treatment starts early.
 
The vaccination campaign is continuing but New Zealand is making a small change while it gathers data. An expert group convened by the government recommended a temporary delay in the administration of second doses, apart from in people with immune disorders. The recommendation reflects evidence that a single dose provides “good levels of protection” and delaying the second dose may improve durability.
 
Medsafe Notice, More
 
TGA cancels pholcodine cough medicines, recalls products over anaphylaxis risk
 
Australia’s Therapeutic Goods Administration (TGA) has canceled the registration of 55 products that contain pholcodine amid concerns about an increased risk of anaphylactic reactions during general anesthesia.
 
The cancellations from the Australian Register of Therapeutic Goods and the recall of the 44 products currently on pharmacy shelves reflect evidence that patients can have sudden allergic reactions if given muscle relaxants during general anesthesia after previously taking pholcodine.
 
“It is difficult to reliably predict who may be at risk of anaphylaxis during anesthesia and some patients may not know if they have taken pholcodine medicines recently. Some patients undergoing emergency surgery may not be in a position to talk to their anesthetist at all,” TGA Head Adjunct Professor John Skerritt said. Alternatives to pholcodine in the treatment of dry cough are available.  
 
TGA reviewed the use of pholcodine in Australia after the European Medicines Agency recommended the withdrawal of the products in its jurisdiction. Up to 9 February, TGA had received 50 reports of suspected pholcodine-related anaphylactic reactions to neuromuscular blockers, including one fatality.
 
TGA Notice, More