Asia Regulatory Roundup: Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies

RoundupsRoundups | 22 October 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies
Hong Kong has proposed legislation to create a regulatory framework for advanced therapy products (ATPs), such as interventions based on cells, genes and tissues. The plan is to amend existing laws to create licensing, labeling and record-keeping requirements for ATPs.
Work to update the law in Hong Kong in light of the rise of ATPs began last year with a consultation. The government took the steps in the belief that “the high risks associated with the rapid scientific advancement” of ATPs means a dedicated regulatory framework is needed to protect public health and support innovation. Differences between production of ATPs and other drugs were also factors.
In the draft legislation shared this week, the government defines ATPs and proposes treating them as a subset of pharmaceutical products. The planned approach means ATPs will be subject to the same requirements as other pharmaceuticals, plus certain rules specific to the modality.
The government plans to make all facilities that produce ATPs obtain a license and comply with good manufacturing practices. Exactly what that means for organizations that make ATPs, which include small sites such as hospitals, will become clearer when the Department of Health provides codes of practice for the industry.
Other sections of the bill state manufacturers of ATPs must provide unique donation identifiers and product codes on their packaging, as well as information found on other pharmaceutical products.
The Legislative Council is due to start reviewing the bill toward the end of the month.
Draft Legislation, Legislative Brief, Press Release
Malaysia Provides Guidance on Regulatory Control of Atypical APIs
The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has shared guidance on atypical active pharmaceutical ingredients (APIs). NPRA expects companies to show batches of atypical APIs comply with specifications set by the finished product manufacturer before they are used.
Version 1.0 of the Malaysian API guidance came into force in April 2018. A section on how the rules applied to ingredients registered before the country implemented a regulatory control directive was added months later. Now, NPRA has updated the guidance for a second time, adding a section on the regulatory control of excipients, food additives and cosmetic ingredients used as APIs in medicines.
When used in medicines, these materials are known as atypical APIs. This subcategory of APIs poses a lower risk than conventional active ingredients, according to NPRA, and is widely used outside the pharmaceutical industry.
In light of the relatively benign safety profile of atypical APIs, NPRA is asking manufacturers for less information about the materials than it requires of companies that handle other active ingredients. The provision of information about topics including process validation and development, stability and impurities is optional for manufacturers working with atypical APIs.
Many of the standard API documentation requirements do apply to atypical materials, though, and NPRA expects batches to be tested before being used in finished products. Responsibility for ensuring safety and quality falls on the finished product manufacturer.
NPRA included a non-exhaustive list of atypical APIs in the updated guidance. The list features 45 ingredients including glucose, L-arginine and sodium bicarbonate that are subject to the atypical API regulatory requirements. NPRA will take will “take appropriate compliance and enforcement action proportional to the risk” if a health threat associated with one of the ingredients is identified.
API Guidance
Number of Random Compliance Reviews Done by TGA Falls by 92%
Australia’s Therapeutic Goods Administration (TGA) has revealed a 92% year-on-year drop in random compliance reviews. TGA performed 12 random reviews in its 2018-19 financial year, down from 143 the previous year.
The targets of TGA compliance reviews are either picked randomly by a computer or selected based on signals that suggest an investigation is needed. In TGA’s 2017-18 financial year, most, 64%, of the companies subject to compliance checks were selected randomly. TGA picked out the remaining 36% of companies that underwent compliance reviews using its targeted, signal-based process.
Those figures changed considerably in the 2018-19 fiscal year, when 91% of companies were chosen by the targeted approach. There is a history of significant fluctuations in the numbers of targeted and random reviews, which have respectively ranged from 41 to 504 and from 87 to 340 in recent years, but even with that context the fall seen in the 2018-19 period is unusual.
TGA shared the data on its compliance reviews in its annual performance statistics report.
TGA Report
New Zealand Follows EMA Lead in Expanding Carcinogen Contamination Probe
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) plans to ask companies that sell medicines containing chemically synthesized active ingredients to assess their contamination risk.
Last month, the European Medicines Agency (EMA) responded to concerns that products other than sartan and ranitidine medicines may be contaminated with nitrosamines by expanding the scope of its investigation. Specifically, EMA asked the marketing authorization holders for all medicines that contain a chemically synthesized active ingredient to assess the risk of contamination.
Now, Medsafe has followed EMA’s lead. While noting that the risk is “very small,” Medsafe wants all companies that supply products with chemically synthesized active ingredients in New Zealand to carry out a review. Medsafe said “a large number” of medicines will be affected by the request.
Medsafe provided the update on the same day as it issued a notice about the availability of sartans, the class of medicines that triggered global concerns about nitrosamines. Sartan products sold in New Zealand can stay on the market despite similar products being recalled in other territories.
The agency confirmed medicines containing valsartan and losartan that are sold in New Zealand can stay on the market after receiving information from their manufacturers. None of the sartans sold in the country are manufactured at sites that use the route of synthesis associated with contamination with nitrosamines. Medsafe tests have confirmed losartan medicines are free of contaminants.
Review Request, Sartan Notice
India to Apply Drug Regulations to Ultrasound Devices in 12 Months
The Indian government has committed to bringing ultrasound equipment under drug regulations on 1 November 2020. The change in the regulatory status of the medical devices will give the Central Drugs Standard Control Organization (CDSCO) more power to oversee their production and sale.
India has a history of applying drug regulations to a subset of medical devices, thereby giving CDSCO oversight of their importation, production and sale. The number of medical devices subject to these additional powers is expanding. In April, India is due to start applying the drug rules to CT, MRI, PET and X-ray imaging equipment. The April change also covers four other types of medical devices.
The latest legislation will bring ultrasound devices under the drug regulation, meaning all commonly used types of imaging technology will be subject to the more stringent rules. India already treats 23 types of medical devices as drugs and will add eight more in the upcoming April update.
Indian officials decided to add the eight types of devices covered by the April update after the Drugs Technical Advisory Board (DTAB) debated whether “high end equipment” should be treated as drugs. That led to a consultation and a legislative notice setting the April 2020 date earlier this year. DTAB voted to apply the drug rules to ultrasound equipment last year.
Gazette Notification, DTAB Minutes


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