Asia Regulatory Roundup: China Looks to End Regional Variation in Trial Oversight (22 December 2015)

Posted 22 December 2015 By Nick Paul Taylor

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Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

China Pushes to End Regional Variation in Strength of Clinical Trial Oversight

The China Food and Drug Administration (CFDA) has committed to ending region-to-region variation in the strength of clinical trial oversight as it’s found that some regions are failing to comply with the more rigorous approach to clinical trial inspections and data quality.

CFDA began its clampdown on subpar clinical trials earlier this year with a view to raising standards while also removing weak marketing applications from its backlog. The initiative has delivered some successes. Earlier this month, 82 companies pulled their drug marketing applications, and CFDA has rejected more filings. Yet, while these moves are a boost to the regulator, with 18,000 filings in the backlog at the last count CFDA knows it is a long way from getting the situation under control

In assessing the ways in which the program is falling short of expectations, CFDA has identified some regions as being less effective than others. “The inspection work in some regions is not being taken seriously enough and the quality of inspection is too low,” the regulator wrote in a notice translated from Chinese by Reuters. CFDA published a seven-point plan this week with a view to encouraging the uniform implementation of its clinical trial oversight and data quality agenda.

The regulator has reminded regional authorities of the process for removing submissions featuring falsified or incomplete data from the backlog of filings. CFDA wants regional officials to investigate any company that refuses to withdraw an application suspected to be substandard. CFDA plans to hold regional office inspectors accountable.

CFDA Notice (Chinese), Reuters

Singapore Seeks Feedback on Plan to Strengthen and Streamline Drug Regulation

The Health Sciences Authority (HSA) of Singapore has started a public consultation on plans to bring all pharmaceutical regulations under a single piece of legislation. In transferring regulations to the Health Products Act, HSA plans to make some changes to strengthen the legislative framework.

HSA is pitching the reshuffle as a way to strengthen and streamline drug legislation in Singapore. If the plan goes ahead, regulatory controls currently overseen by the Medicines Act and Poisons Act will move to the all-encompassing Health Products Act. HSA sees this move streamlining regulations. Many of regulatory controls will undergo few, if any, changes during the transfer, but HSA wants to use the move as an opportunity to strengthen its activities in certain areas.

The new document will step up post-marketing surveillance in Singapore, notably by supporting the use of risk-management plans and filings of evaluations of benefits and risks. HSA wants to change how it approaches the maintenance of records and reporting of defective products, too, while also revising the timelines in which serious adverse events must be disclosed. Other changes relevant to approved products include the need to name a responsible person in license applications.

Experimental drugs would be affected by the new legislation, too. HSA intends to take a risk-based approach to the oversight of clinical trials, while also tweaking the legal provisions with a view to improving transparency and facilitating global development programs. A new notification system for clinical trial materials is part of the plan. By phasing out the existing import approval system, HSA thinks it can improve access to clinical trial materials.

HSA is accepting comments on the proposals until 15 January.    

Press Release, HSA Documents

Australia Adds Adverse Event Reporting Requirements to Biosimilar Regulations

The Therapeutic Goods Administration (TGA) of Australia has published version 2.0 of its biosimilar regulations. New additions to the document include a section on adverse events, in which TGA sets out the information companies should provide when reporting suspected side effects of biosimilars.

TGA is aiming to ensure that every adverse event report it receives clearly identifies the medicine linked to the incident. The regulator wants to be informed of the brand identity of the biosimilar, as well its non-proprietary name. TGA is using the Australian biological name as the non-proprietary identifier of biosimilars. Other details requested by TGA include the AUST R and batch numbers, plus the expiration date and dosage form.

The other wholly new section in version 2.0, which replaces a text that came into force in 2013, covers the data requirements for biosimilars. “Before a biosimilar medicine can be registered in Australia, a number of laboratory and clinical studies need to be performed to demonstrate the comparability (biosimilarity) of the new biosimilar to the reference biological medicine already registered in Australia,” the section states.

TGA has based its approach to this and other aspects of biosimilars on guidance documents created by the European Medicines Agency (EMA). The new version of the regulations includes an updated list of EMA guidance documents. TGA has also expanded multiple other sections of the document, including the text outlining its approach to reference medicines, which now dictates when and how companies can compare their biosimilars to products that are not registered in Australia.

TGA Regulations

CFDA to Create Database of Drug Company Credit Ratings

CFDA is to create a database of the credit ratings of drug companies. The plan, full details of which are yet to emerge, would see companies be punished and publicly shamed when their credit rating fell below a certain level.

Officials at CFDA plan to have the first iteration of the system in place by the end of next year. That early version will set the basic design of the system, but building up the data will take time. By the time the third iteration of the system goes live in 2020, CFDA wants to have a significant pool of data that are shared between national and regional regulatory officials. Each company will have a credit rating of either A, B, C or D. Companies that lack creditworthiness could face punishment.

State news agency Xinhua described the data being gathered as “safety credit ratings,” implying that CFDA is looking to gather more than just financial information. As FiercePharmaAsia notes, China is in the middle of implementing a similar system for the general population. Instead of just collecting data on the creditworthiness of individuals, as many states do, China will also rate people on their compliance with social norms dictated by the government.

CFDA Notice (Chinese), Xinhua, FiercePharmaAsia

Other News:

The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has warned the industry about phone calls from people pretending to be on its staff. PMDA said companies have received calls from people falsely claiming to work for the regulator. The callers have asked to survey quality management systems and other aspects of businesses. PMDA Notice (Japanese)

TGA started a consultation on whether it should adopt a clutch of EMA documents. The texts cover guidelines on the clinical development of multiple classes of products, including treatments of acute heart failure, plus a reflection paper on the selection and justification of starting materials used to make active pharmaceutical ingredients. TGA Notice

Taiwan has given pharmaceutical manufacturers until June to revise their packaging to comply with new requirements. The new packaging regulations are intended to make it easier for consumers to understand the information being conveyed. As it stands, a survey suggests more than half of patients do not know the name of the drug they are taking. Tapei Times

 

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Categories: Biologics and biotechnology, Drugs, Clinical, Due Diligence, Distribution, Government affairs, Manufacturing, News, Asia, PMDA, CFDA, MFDS, CDSCO, TGA, Medsafe, ANZTPA, IMDRF

Tags: Asia regulatory affairs, CFDA, TGA, CDSCO, PMDA

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