Asia-Pacific Roundup: India simplifies regulatory framework for outsourced sterilization of medical devices
The Indian government has simplified the regulatory framework for outsourced sterilization of medical devices as part of a push to support businesses.
Under its “ease of doing business” drive, the government has tried to simplify regulatory compliance for medical device manufacturers working with outsourced sterilization facilities. The framework, which was recently finalized following a consultation, eliminates the need for companies to obtain a separate loan license for the outsourced sterilization activity.
Eliminating the loan license requirement when outsourcing work to facilities holding valid licenses under the Medical Devices Rules, 2017, will reduce duplication, administrative burden, compliance costs, and associated timelines, the government said. Officials see particular benefits for manufacturers that lack in-house sterilization facilities.
The new framework “seeks to strike a balance between regulatory oversight and ease of doing business by simplifying the licensing framework while retaining an essential traceability mechanism for outsourced sterilization,” the government said. Expected benefits include greater operational flexibility, faster and more efficient manufacturing processes, and a more competitive medtech industry.
Following the change, manufacturers should include the license number of the outsourced sterilization site on the labels of their devices. The government has provided a six-month transition period to give the industry time to make necessary changes to their labeling, packaging, and related processes.
Officials disclosed the framework alongside news that the government has added the European Union to the list of recognized stringent regulatory jurisdictions for waiving clinical investigation requirements for medical devices without predicate products. Previously, the Medical Devices Rules, 2017, only named the US, UK, Australia, Canada, and Japan as recognized jurisdictions.
Because of the update, “eligible medical devices that have already been approved in the EU will be able to benefit from the waiver provisions, facilitating faster patient access to advanced medical technologies in India,” the government said. Officials expect the change to simplify regulatory processes, reduce costs, enhance transparency and predictability, and facilitate timely access to medical devices in India.
Press Release, Gazette Notification
Medsafe shares guidance on clinical trial processes in New Zealand
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has published guidance on clinical trial processes for sponsors.
Medsafe’s guidance ranges from applications for Phase 1 trials to drug safety update reports (DSURs). In the Phase 1 section, the agency clarified that it will reject submissions to run first-in-human (FIH) trials if the applicant files before all the preclinical information is available. Similarly, sponsors should only file to run Phase 1 studies once they have completed their FIH trials.
Sponsors that apply before they have the required information will need to resubmit. Medsafe’s position reflects its belief that the information from preclinical and FIH tests is needed to inform the protocol for the subsequent stage of development.
In the DSUR section, Medsafe cited legislation requiring sponsors to file progress reports for approved trials every six months. Sponsors may use DSURs rather than one of the standard six-monthly progress reports, Medsafe said. The guidance includes advice on how to synchronize the timing of the annual DSUR and six-monthly progress reports.
Other sections of the guidance address protocol amendments and new investigators. Sponsors should submit protocol amendments using the SCOTT post-approval form in the Ethics Review Manager, the agency said. While Medsafe aims to review changes within one week, it cautioned that it can take longer to address substantial revisions.
Sponsors can support reviews by clearly describing all substantial amendments and providing a rationale for each change. Medsafe will reject amendments that fundamentally change the approved clinical trial such that the resulting protocol is, in effect, a new study. The agency cited changes to the investigational product, study population, and indication as examples of revisions that may constitute a new study.
Medsafe’s guidance on new investigators covers the information sponsors should submit about their collaborators. For each new trial investigator, the agency expects to receive a signed protocol signature page, an up-to-date CV, and evidence of recent good clinical practice training.
WHO adds collaborating center in Korea and partners with Peking University
The World Health Organization (WHO) has named the Republic of Korea’s Global Harmonization Centre (GHC) as a collaborating center for health products regulatory system strengthening and training.
Designating GHC, which works under Korea’s Ministry of Food and Drug Safety, as a WHO collaborating center is intended to expand access to structured, competency-based regulatory training and strengthen the regulatory workforce for medicines and vaccines across countries. WHO framed the designation as a response to challenges including a shortage of skilled regulatory professionals.
“This new collaborating center will allow us to build on the Republic of Korea’s considerable regulatory expertise and training experience to expand support to countries and strengthen regulatory capacity where it is most needed,” Hiiti Silo, WHO unit head, regulation and safety, regulation and prequalification department, said.
WHO shared details of the designation days after unveiling a two-year collaboration with China’s Peking University. The partners will conduct operational and implementation research on health emergency preparedness and develop and deliver training on WHO preparedness tools and approaches. Other goals include developing methodologies to assess investments in preparedness.
The collaboration will run to 31 July 2018. WHO and Peking University could extend the partnership by mutual agreement.
IPC creates manual for reporting medical device adverse events in India
The Indian Pharmacopoeia Commission (IPC) has published a user manual for the country’s Adverse Drug Reactions Monitoring System (ADRMS).
ADRMS supports the Materiovigilance Programme of India (MvPI), a scheme through which IPC monitors adverse events related to medical devices. Stakeholders with medtech adverse events to report can log in to ADRMS to share the information with the MvPI. The IPC user guide explains how to complete the nine sections of the medical device adverse event reporting form.
Points explained in the user guide include how to complete the “primary reporter” section. When the device license holder is reporting information a hospital or patient shared with its team, the company must name the healthcare professional, consumer, or user as the primary reporter.
Another section of the user guide explains how to report a “near-miss incident.” Unplanned events that had the potential to cause injury, illness, or damage but did no harm to the patient are classed as near misses. Stakeholders completing the form must provide the date the near miss happened.
Medsafe lifts limit on vitamin D, advances changes to antipsychotic monitoring
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its position on vitamin D levels and monitoring of an antipsychotic drug following consultations.
Medsafe’s vitamin D consultation found support for increasing the amount of the nutrient that is allowed in general sale medicines. The support led Medsafe to allow up to 50 micrograms of vitamin D in general sale medicines, up from 25 micrograms under the previous classification. Products with more than 50 micrograms of vitamin D can only be provided on prescription.
The agency shared the reclassification days after reporting the outcome of a consultation into the blood monitoring and prescribing requirements for clozapine, an antipsychotic used in treatment-resistant schizophrenia. Based on the feedback, Medsafe plans to allow patients to stop mandatory monthly blood monitoring after two years of continuous treatment. The clozapine changes will take effect in March.
