Asia-Pacific Roundup: CDSCO seeks feedback on applying to import in vitro diagnostics into India
The Central Drugs Standard Control Organization (CDSCO) has started a consultation on guidance about importing in vitro diagnostics (IVDs) into India.CDSCO, which is accepting feedback for 15 days, has created the document to advise importers on filing product license applications through the “cdscomdonline” and “NSWS” portals. Companies should use the cdscomdonline portal for import license applications. The NSWS portal is reserved for licenses to import limited quantities of an IVD for noncommercial uses, such as testing, training, and clinical trials.
The draft is a consolidated reference document about the standards and regulatory requirements that apply to companies importing IVDs into India. CDSCO has covered the applicable regulatory framework, procedural steps, documentation requirements, and compliance obligations that importers must fulfil to comply with the Medical Devices Rules, 2017.
To support importers, CDSCO has provided charts showing which license they need to bring a product into the country and the pathway that applies to companies operating under each type of license. For example, CDSCO said a fresh import license applies to first-time applications and requires companies to submit particular paperwork including a MD-14 application.
The guidance includes checklists of the materials importers need to submit with each type of application. CDSCO has differentiated between commercial and noncommercial filings, and divided the commercial requirements based on whether the applicant is filing for the first time, adding products or an agent to an existing license, or renewing a license.
Having defined what materials are mandatory, CDSCO spends most of the rest of the document sharing details of exactly what companies need to submit to meet the requirements. The covering letter must be written on the company’s official letterhead, be signed by the authorized signatory, and explicitly specify the purpose of the application. CDSCO has provided similar details for each requirement.
Draft Guidance
NMPA briefs FDA about recent changes to China’s Drug Administration Law
Leaders from the National Medical Products Administration (NMPA) have met with a US delegation to discuss matters including incoming changes to China’s Drug Administration Law.
Yang Sheng, deputy commissioner of China’s NMPA, met the delegation. The delegation was led by Mark Abdoo, the US Food and Drug Administration’s (FDA) associate commissioner for global regulatory operations and policy. Abdoo has visited China several times in recent years, reflecting his involvement in the oversight of FDA’s foreign offices and work to integrate global considerations into agency policies.
NMPA said Sheng and his colleagues used the recent meeting to brief Abdoo on the incoming changes to China’s Drug Administration Law. China’s State Council released full details of the changes, which are intended to incentivize innovation, around the time of the meeting with Abdoo. The changes will take effect on 15 May. NMPA also shared other updates on China’s drug regulation.
Abdoo and his colleagues provided updates on the FDA’s work on supply chain security, the creation of a regulatory framework for digital health products, and the development of regulations for medical device quality management systems, NMPA said.
Both sides engaged in in-depth exchanges on drug imports and exports, pharmacovigilance, and the use of new methodologies, according to NMPA. The Chinese regulator said attendees expressed a willingness to continue practical cooperation.
Press Release
CDSCO floats updates to rules on manufacturing changes, ethics committees
India’s CDSCO has released draft changes to the New Drugs and Clinical Trials Rules for consultation.
CDSCO proposed the changes across two notices. One notice described the planned insertion of a new rule about changes to a product’s manufacturing process, excipients, packaging, shelf life, specifications, testing, or documentation. When making such changes, the company or its authorized agent must tell the licensing authority in writing.
The proposal would establish different rules for minor, moderate, and major quality changes. CDSCO plans to define major changes as revisions that have “a substantial potential” to adversely affect the product’s identity, strength, quality, purity, or potency. Companies will need prior approval from the licensing authority to make major changes. Changes with a moderate potential to adversely impact a product will also require prior approval.
CDSCO has proposed allowing companies to make minor changes without prior approval. Instead, companies will submit annual reports of minor notifications in the first quarter of each calendar year.
The other notice affects the registration of ethics committees. CDSCO has proposed deleting text about ethics committees gaining provisional registration for two years. Under the draft rules, authorities will grant final registration to ethics committees that meet the requirements. CDSCO will reject submissions that do not meet the requirements and explain its decision in writing.
Draft Rules, More
Japan’s PMDA posts guidance on developing hypertrophic cardiomyopathy drugs
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared advice for developers of drugs to treat hypertrophic cardiomyopathy (HCM), a condition defined by the thickening of heart muscle.
As PMDA noted in its early advice document, HCM is classified into obstructive and non-obstructive forms. The agency said sponsors should run separate confirmatory studies for each phenotype because of differences in pathophysiology and prognosis. Because both forms of HCM are rare, sponsors should actively consider including Japan in multi-region clinical trials from early in development, PMDA said.
PMDA may allow sponsors to refer to the results of an overseas trial to support the evaluation of efficacy and safety in Japanese patients if they have domestic data for comparison. The model may be applicable when a sponsor has already shown efficacy in an overseas confirmatory trial or when Japanese sites cannot be added to an ongoing overseas confirmatory trial.
The agency published the guidance alongside translations of early advice documents about the use of a weight of evidence approach in nonclinical safety evaluation and as an alternative to nonhuman primate studies. PMDA posted Japanese-language versions of the documents in October but only recently shared translated copies.
PMDA Guidance
India aims to accredit 1,000 clinical trial sites in bid to become biopharma hub
The Indian government has put the accreditation of more than 1,000 clinical trial sites at the center of its plans to establish the country as a global biopharma hub.
As part of the presentation of India’s annual budget, the country’s finance minister said the government will create a network of trial sites to enhance the quality and credibility of clinical research in India and accelerate drug development timelines. Ultimately, the government wants the investment to improve domestic access to new therapies and create opportunities for researchers and medical professionals.
The clinical trial commitment was part of a broader plan that includes investment in local production of biologics and biosimilars. The government pitched the manufacturing program as a way to reduce India’s dependence on imports and strengthen healthcare security.
Press Release
Other news:
The Philippine Food and Drug Administration (FDA) has scheduled a meeting to discuss changes to its fees. FDA suspended changes to its fee schedule last year in response to concerns about the impact on companies and other matters. After extending the suspension twice, FDA is now seeking input on its next steps. FDA Notice
Malaysia’s Medical Device Authority (MDA) will start issuing free sale, manufacturing, and export certificates electronically on 1 March. MDA will email certificates within seven business days of receiving payment for a successful application. MDA Notice
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