Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Ex-CFDA Chief to Lead China’s New Regulatory Organization
China has appointed Bi Jingquan as first secretary of its new umbrella regulatory organization the National Market Supervision Administration (NMSA). The appointment gives Bi, who led the China Food and Drug Administration (CFDA) for the past four years, a vital role in the new regulatory structure.
Bi’s appointment provides continuity and supports the view, expressed by consultancy China Med Device to Focus
earlier this month, that the reorganization will have minimal effect on the day-to-day activities of CFDA section heads.
While Bi is a familiar face, some of the other people now overseeing drug regulation in China have a lower profile in regulatory circles. At NMSA, Zhang Mao has taken on the director role. Zhang has some healthcare experience through his time in the Ministry of Health, according to a China Med Device report, but he has spent his career in areas outside of drug and device regulation.
Bi’s appointment means drug and device regulation are represented in the upper echelons of NMSA’s leadership, though, and the organization has made changes further down the management structure to account for the broadening of his responsibilities.
Jiao Hong has filled the leadership position created by Bi’s elevation to the NSMA post. Jiao will lead the State Drug Administration, an organization operating under NSMA and apart from the State Food Administration. The new leader joined CFDA six years ago and made her mark with several important initiatives, including China’s efforts to join the International Conference on Harmonisation and start performing overseas inspections.
Jiao inherits the leadership position at a time when the drug administration is working to realize the government’s demands for it to help get innovative medical products to Chinese patients faster. Li Keqiang, the Chinese premier, touched on those issues in a speech to the National People’s Congress, in which he called for the reform of drug supervision.
Xinhua, Keqiang Speech
(both Chinese), China Med Device Post
India Relaxes Export Rules to Reduce Regulatory Burdens
The Drug Controller General of India (DCGI) Eswara Reddy has relaxed rules covering the export of drugs and medical devices. The changes free exporters from the need to obtain a no objection certificate (NOC) before shipping products.
India began liberalizing its export rules in 2015 by freeing companies of the need to get an NOC before sending consignments to North America, Japan, Australia or the European Union. This week’s action extends that more relaxed regulatory approach to all countries. The only caveat is companies must file shipping bills themselves and possess valid licenses under Indian legislation.
Reddy framed the action as an attempt to “bring ease” to the regulatory practices governing the export of drugs and devices from India. That thinking is in keeping with broader, ongoing attempts to make India a better place to do business.
In the case of the NOC exemption, the policy has freed manufacturers from the need to send several pieces of paperwork to Indian authorities. Filings for export NOCs must include a cover letter that details the intent of the application, a purchase order from the foreign buyer, a manufacturing license, a pro forma invoice and a registration certificate.
TGA Posts Guide to Extending Regulatory Drug Designations
The Therapeutic Goods Administration (TGA) of Australia has shared a step-by-step guide to extending regulatory drug designations. The guide walks sponsors through the process for extending previously granted provisional determination and orphan drug designations.
TGA’s walkthrough overlaps with a previously published document on making initial applications for regulatory designations, but the information sponsors must provide differs in some notable ways. When seeking to extend an existing designation, sponsors must answer a question about their plans to file for approval by the end of the revised end date of the regulatory status. That question is absent from the initial application process.
TGA released the extension application walkthrough alongside an update to the existing guide about making initial applications for regulatory designations. The revised version adds information related to the provisional approval pathway, which was yet to go live when TGA released the original guide in July.
The process for applying for provisional determination — which allows drugs to come to market on the basis of preliminary clinical data — is similar to that for the priority review status. In both cases, the applicant must answer questions about the novelty of its product, the severity of the condition it treats, the availability of alternative therapies and the extent to which the drug represents a major therapeutic advance.
The big differences are companies seeking provisional determination only need preliminary data, not substantial evidence, that a drug is a major advance, but they must also provide a clinical study plan showing how they will generate more substantive results.
, Application Guide
CDSCO Answers Another Set of Questions About Medical Device Rules
The Central Drugs Standard Control Organization (CDSCO) has released another question and answer document about its medical device rules. The document focuses on the regulatory status of activities that bridge the outgoing and incoming legislative regimes.
One question addresses the status of applications for licenses that were made before the start of 2018 but are still being processed. In these cases, CDSCO expects the applicant to pay the balance of the fees and reapply through the online portal. That makes the applications subject to the recently-enacted medical device rules, despite being submitted under the former regime.
CDSCO has adopted a similar stance on applications for import made before the start of 2018 on the old Sugam system that were never finished due to incomplete documentation or other issues. The companies behind such applications must reapply through the new online portal and submit the extra fees and documents associated with the revised regulatory process.
The other transition between regulatory regimes addressed by the document covers the renewal of manufacturing licenses. CDSCO moved to an automatic renewal system late last year. The change freed companies from the need to actively seek renewal, beyond paying a retention fee, but caused some uncertainty. CDSCO has now clarified that licenses “remain valid perpetually,” regardless of when they were issued.
has amended legislation about the labeling of drugs and fixed-dose combinations (FDC). The revised rules state manufacturers must print the proper name of the drug or drugs contained in the product in a “conspicuous manner.” This text must be written in a font at least two sizes bigger than that used for the brand name. The brand name must be printed in brackets or after the proper name. Gazette Notification
is seeking feedback on regulations related to the assessment and approval of changes to drug production sites. The agency framed the provisions as a way to encourage the merger of holders of drug marketing and manufacturing licenses, while also promoting the adoption of new production technology. The draft is open for comment until 19 April. CFDA Notice
has published guiding principles on continuous glucose monitoring systems. The document provides a detailed technical overview of the devices, how they are used and similar products, before going into the evidence applicants should submit to support requests for approval. CFDA is aiming the document at both applicants and reviewers. CFDA Notice