Asia-Pacific Roundup: India’s ICMR proposes single ethics committee reviews to streamline multicenter trials
The Indian Council of Medical Research (ICMR) has outlined plans to adopt a single ethics committee review mechanism for clinical trials.Study sponsors currently need ethics committee approval at each Indian site participating in a trial. ICMR has tried to streamline the system, which causes delays, for years. The organization adopted a common ethics review approach in 2017. In 2023, ICMR proposed a joint process in which ethics committees meet online to reach a harmonized decision.
However, the 2017 and 2023 models have each faced significant operational and logistical constraints that have prevented their widespread adoption, ICMR said. In response, the organization has proposed a single ethics committee review mechanism designed to streamline the process.
Under the proposal, sites participating in a trial would identify a single ethics committee to review the study protocol, including all core and site-specific documents. The ethics committee would provide consolidated comments to the principal investigator. Once the investigator provided satisfactory responses, the committee would grant an ethics approval covering all participating sites.
ICMR has identified limitations of the approach, including the potential for the single ethics committee’s lack of knowledge of site-specific ethical issues to compromise reviews. The organization has attempted to address the limitations in the draft operational guidelines, which describe all the steps from protocol development to study completion and dissemination in detail.
Draft Guidelines
Philippine FDA seeks feedback on using digital platforms for marketing authorizations
The Philippine Food and Drug Administration (FDA) has proposed moving all marketing authorization applications to digital regulatory platforms.
FDA said the increasing volume and complexity of applications for marketing authorization necessitates streamlined use of electronic systems to support the submission, evaluation, and issuance of marketing authorizations. The agency framed the move as in line with the World Health Organization’s support for structured, transparent, consistent, and well-documented review processes.
Under the draft proposal, FDA will use digital submission platforms such as its eServices Portal System to receive initial, renewal, and post-approval change applications for human medicines. FDA will send all official communications, including notices of deficiency and regulatory decisions, electronically through the portal or via official registered email systems.
FDA’s proposal lacks a defined transition period. However, the agency said manual submissions will continue until the online platform is fully implemented. FDA established digital processes for automatic renewals, principal certificates of product registration conversion, and certificates of listing of identical drug products in 2021. The agency attached guides to those processes to its call for comments.
Officials plan to publish technical guidelines and advisories to support full digital implementation. FDA’s draft for comments only features a high-level overview of how filing assessments, payments, and regulatory decisions will happen under the digital system.
The agency is accepting feedback until 10 April.
FDA Notice
New Zealand’s Medsafe extends transition to new steroid rules after industry feedback
New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) has given manufacturers 24 months to transition to new labeling rules for topical corticosteroids after reviewing industry feedback.
Medsafe consulted on planned changes to the rules last year. Noting that patients may be prescribed multiple topical corticosteroid products of varying strengths, Medsafe proposed requiring companies to more clearly state the potency of the medicine on the container or packaging. The changes are intended to prevent the inappropriate overuse of topical corticosteroids.
While 90% of the 60 respondents agreed with the plan to add a potency statement, only one of the five industry representatives that commented supported the proposal. Even so, the overwhelming support of healthcare professionals and the public led Medsafe to say most respondents agreed with the proposal.
Medsafe originally proposed an 18-month transition period. However, industry respondents said they would need at least 24 months to implement the label update. Companies said they need the extra time to develop new labels, win approval in Australia, and manage their existing stock, which generally has a long shelf life. Medsafe cited shelf-life as a driver of its decision to extend the transition to 24 months.
The agency also clarified the scope of the labeling requirement and changed the terms used to describe product potency in response to the feedback. Medsafe narrowed the scope to topical treatments of inflammatory skin conditions, excluding cold sores, after respondents argued potency labeling may not be relevant for products used in acute conditions.
Officials dropped plans to use the terms mildly potent, moderately potent, potent, and very potent to describe products after respondents called for more consumer-friendly language. The final requirement is to label products as mild, moderate, strong, or very strong steroids.
Medsafe Notice
Malaysia’s MDA makes Singapore reliance program permanent after successful pilot
Malaysia’s Medical Device Authority (MDA) has created a permanent accelerated authorization pathway for certain devices registered in Singapore.
MDA and Singapore’s Health Sciences Authority (HSA) began piloting the abridged review program last year. During the verification route pilot, MDA reviewed Class B, C, and D devices registered in Singapore in 30 working days, compared to 60 under the full conformity assessment. HSA shortened its reviews of devices registered in Malaysia by 30%.
The pilot ended on 28 February, but MDA established a permanent verification route the next day to keep providing an accelerated path to market for devices registered in Singapore. HSA has yet to publish a statement on its plans. MDA said an official press release is scheduled for publication during the 29th IMDRF Management Committee Meeting, which HSA is hosting this week.
Separately, MDA exempted certain tenders from rules that took effect on 28 January. Tender processes that began before the new rules took effect are exempt until the contract expires or the activity ends. MDA implemented the exemption to ensure the smooth administration of procurement activities and the continuity of medical device supply.
MDA Notice
CDSCO posts alert about theft of Sanofi diabetes drugs during transit in India
India’s Central Drug Standard Control Organization (CDSCO) has published an alert about the theft of Sanofi diabetes drugs during transit.
Sanofi’s Indian division told CDSCO that a batch of Lantus SoloStar, an insulin product, was stolen while being shipped to a logistics intermediary. The product must be kept between 2-8 degrees Celsius, leading CDSCO to warn that quality could be compromised if the medicines are not handled properly. Storing products outside the required temperature range could affect patient safety, CDSCO said.
The report comes months after Novo Nordisk told CDSCO that thieves stole batches of its insulin drugs. As in the Sanofi case, the Novo drugs were stolen during transit and CDSCO published an alert about the theft because of risks related to keeping the products outside of the required temperature range.
CDSCO Notice
Other News:
Australia’s Therapeutic Goods Administration (TGA) has shared two good manufacturing practice (GMP) consultations by the Pharmaceutical Inspection Co‑operation Scheme (PIC/S). The PIC/S concept papers cover annexes to its GMP guide about medicinal gases and qualification and validation. TGA has adopted the current versions of the annexes. TGA Notice
TGA has published an updated safety advisory after testing confirmed imported weight loss products are counterfeit. Testing showed the products falsely claim to contain GLP-1 receptor analogs. TGA ran the tests on several imported unregistered products that were labeled as containing GLP-1s. TGA Notice
