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Asia Regulatory Roundup: China Approves Amgen and GSK Products Under Overseas Fast-Track Scheme

Posted 28 May 2019 | By Nick Paul Taylor 

Asia Regulatory Roundup: China Approves Amgen and GSK Products Under Overseas Fast-Track Scheme

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Philippine FDA Shares Draft Rules on Clinical Trial Conduct for Comment
The Philippine Food and Drug Administration (FDA) has issued draft regulations on the conduct of clinical trials. The document sets out general principles covering clinical trials run in the Philippines, as well as more specific points addressing each step from application to termination.
FDA will require all organizations that perform clinical trials in the Philippines to comply with good clinical practices and get a license to operate. The rules also require companies to upload details of their clinical trials to a registry, follow International Conference on Harmonisation requirements on the reporting of unexpected serious adverse reactions and inform FDA of any inspections performed by foreign regulatory agencies.
The more specific guidelines flesh out what these requirements will mean in practice. For example, FDA is threatening to impose sanctions on applicants that file falsified data or withhold information. Other sections of the text state the timelines for tasks including the uploading of information to the clinical trial registry — 30 calendar days — and set out the process for amending study protocols.
FDA is accepting feedback on the draft until 9 June.
Two days after publishing the draft, FDA released a circular to amend the clinical trial regulations it issued in 2012. The changes, which come into force on 1 June, center on the process for getting clearance to run clinical trials and import investigational medicinal products into the Philippines.
The 2012 circular gave regulatory reviewers 60 days to assess applications and charged sponsors PhP 30,000 ($574) per filing. The amended process cuts the regulatory review time to 45 days, although 30 days of pre-acceptance evaluation and post-review decision making will mean it will take longer than that for sponsors to receive clearances to start studies. The new filing fee is PhP 60,000. 
A separate process governs applications for licenses to import investigational products but, under the new approach, FDA is permitting parallel applications for the two required clearances. Seeking clearance to run a clinical trial and import the drug used in it at the same time could truncate timelines.
Draft Regulations, FDA Circular
CDSCO Creates Process for Companies That Lack Data Supporting Their FDCs
India’s Central Drugs Standard Control Organization (CDSCO) has established an authorization process for fixed-dose combinations (FDCs) that came to market despite lacking the required data. CDSCO’s process covers FDCs that require either a Phase IV trial or active surveillance to stay on the market.
In its assessment of hundreds of FDCs that came to market via a back door, India identified 278 drug combinations that may be rational but are supported by insufficient data. CDSCO originally planned to require all manufacturers of these FDCs to perform Phase IV clinical trials but, following feedback from industry, has since limited its requirements for some products to active surveillance.
Now, CDSCO has created a process for manufacturers in either situation to follow. Manufacturers that brought FDCs to market via state licenses must submit assorted forms, plus either a Phase IV trial protocol, commitment to perform active postmarket surveillance or a bioequivalence study protocol, depending on the requirements imposed by CDSCO.
Manufacturers that want to bring versions of the disputed FDCs to market for the first time face a slightly different set of requirements. CDSCO expects companies in this situation to file data from stability studies and supply test specifications of the FDC, in addition to the paperwork demanded from all manufacturers.
CDSCO expects companies to supply the requested materials within six months. Failure to comply with the timeline will invalidate the existing product licenses, CDSCO said, although the agency has struggled to get the industry to comply with deadlines in the past.
CDSCO Notice
China Approves Amgen and GSK Products Under Overseas Fast-Track Scheme
China’s National Medicinal Products Administration (NMPA) has conditionally approved products sold by Amgen and GlaxoSmithKline. The drug and vaccine were fast tracked through the process as part of China’s push to make certain products available in the country.
Last week, NMPA revealed Amgen’s Xgeva and GSK’s Shingrix to be the 14th and 15th products to come to market under the overseas fast track. NMPA initiated the program to encourage the manufacturers of certain products already approved in other markets to seek approval in China, thereby addressing gaps in the range of drugs and vaccines available in the country.
NMPA approved Amgen’s Xgeva for use in patients with giant cell tumor of bone that is unresectable, either because the procedure is impossible or because it would likely result in severe morbidity. The US Food and Drug Administration (FDA) approved Xgeva in the indication early last year.
The lag between approval of Shingrix in the US and China was a little longer but still very short by historical standards. FDA approved the vaccine in adults aged 50 years and older in October 2017.
NMPA followed FDA’s lead despite neither Amgen nor GSK having the comprehensive set of China-focused data typically required for authorization in the country. The flexibility shown by NMPA reflects a belief that Xgeva and Shingrix address important gaps in the medicines and vaccines available in China.
To compensate for the lack of local data, NMPA is putting postmarket requirements on Amgen and GSK. NMPA expects Amgen, for example, to continue to perform clinical trials of Xgeva in China and develop a risk-management plan to mitigate the potential for harm.
Despite the flexibility shown by NMPA, many drugmakers are yet to avail themselves of the overseas fast track. China has offered the fast track to 78 products. Fifteen have come to market under the pathway to date.
Shingrix Notice, Xgeva Notice (both Chinese)
China’s NMPA Strengthens Oversight of Imported Medicinal Materials
NMPA has taken steps intended to increase oversight of imported medicinal materials. The rules place different requirements on first time and repeat imports.
In the guideline, NMPA details the regulatory bodies that oversee medicinal material imports and the process for applying to bring the materials into China. The process for materials entering China for the first time requires applicants to send samples to the local drug inspection agency. Officials at the agency have 30 days to test the samples.
Applicants have the right to challenge the results of the assessment. If that happens, the inspection agency has 20 days to reassess the samples. 
Another section of the text deals with the ongoing oversight of importers, including the power of port authorities to seize materials if they have evidence of a threat to human health. China can issue fines of up to RMB 30,000 ($4,343) to importers that submit false materials or otherwise engage in deceptive practices.
The new measures are due to come into force at the start of next year.
NMPA Order (Chinese)
Other News:
The Philippine FDA has asked manufacturers of diabetes, high cholesterol and hypertension drugs to submit details of the products. The Philippines freed such products from value-added tax at the start of the year, but FDA subsequently received reports that some drugs were missing from the list of therapies eligible for the exemption. FDA’s request is intended to fill in the gaps. FDA Notice
Australia’s Therapeutic Goods Administration (TGA) has released a summary of the fees and charges it will enforce from 1 July onward. TGA Summary


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