Asia Regulatory Roundup: China Opens Regulatory Fast Track to Manufacturers of Coronavirus Equipment

RoundupsRoundups | 11 February 2020 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China Opens Regulatory Fast Track to Manufacturers of Coronavirus Equipment
China’s National Medical Products Administration (NMPA) is fast tracking the processing of requests to manufacture and sell face masks and other pieces of medical equipment capable of slowing the spread of the coronavirus.
NMPA has created the fast track to encourage manufacturers of medical clothing to add capacity, reassign existing capacity to products related to coronavirus or enter the Chinese market for the first time. Such changes require regulatory approval, but under emergency measures adopted by NMPA, will be less burdensome to implement than in the past.
The revised regulations position NMPA to combine inspections related to the granting of production licenses and device registrations. NMPA will issue licenses and registrations simultaneously, although both clearances will expire in one year.
Some medical equipment manufacturers have already taken advantage of emergency measures in place at NMPA. The agency has approved 72 device registration applications under its emergency approval procedure.
NMPA is working to get new devices to market quickly while also stopping manufacturers of fake and substandard products from exploiting the situation. NMPA issued a separate statement last week about its enforcement activities, stating that it will strengthen its random inspection program and severely punish illegal activities.
NMPA Notice, More (both Chinese)
Australia Creates Guidance on Microbiological Quality of Medicinal Cannabis
Australia’s Therapeutic Goods Administration (TGA) has published guidance to help manufacturers of medicinal cannabis products comply with microbiological standards. The guidance notes that it may be hard for manufacturers to comply with some of the standards, as medicinal cannabis products are derived from plants.
TGO 100, the document that details microbiological standards for medicines, requires that products are not contaminated with certain microorganisms. In the case of non-sterile medicines containing a raw material of natural origin, such as cannabis products, manufacturers must comply with either British, European or American rules on the microbiological examination of non-sterile products.
TGA thinks compliance with that rule “might be challenging for some dosage forms, such as those that are taken orally or inhaled.” Manufacturers of oral dosage forms can ask TGA to use special European Pharmacopoeia provisions that “include requirements for absence of pathogenic enteric bacteria that could be present in botanical material, but not expected to be present in a pharmaceutical medicine.” TGA sees that special provision as preferable to the standard rule.
The situation facing manufacturers of medicinal cannabis products delivered via inhalation is less clear. As TGA notes, the pharmacopeia quality criteria for inhaled products date back to 2005, years before inhalants were produced from botanical materials for administration via smoking or vaping.
TGA has identified a need for alternative, risk-based microbiological criteria for inhaled cannabis. The criteria would need to protect users, be achievable by industry and be suitable for use as a regulatory tool. However, TGA lacks the information to propose such a tool, leading it to call for regulators and industry to assess the microbiological histories of finished products and use that information to make risk-based microbiological specifications for inhalants. 
In light of the current lack of such specifications, TGA is allowing manufacturers of inhaled medicinal cannabis products to seek exemption from parts of TGO 100. Applicants will need justify the request and propose alternative microbiological quality criteria to get TGA to grant an exemption.
TGA Guidance
India Proposes 5-Year Prison Sentences for People who Break Advertising Rules
The Indian government has proposed jailing people who break medicine advertising laws for up to five years. If the law passes, Indian courts will gain the power to imprison first offenders for up to two years and lock up people who repeatedly break the law for up to five years.
Under the current Indian legislation on the advertising of “drugs and magic remedies,” the courts can sentence people who break the law once for up to six months in prison. Subsequent convictions can carry a prison sentence of up to one year. The existing legislation also permits the imposition of fines on first-time and repeated offenders but does not state how much they can be made to pay.
The draft legislation features tougher sentences. In addition to the longer prison sentences, the draft text empowers the courts to hit first-time offenders with fines of up to Rs 1 million ($14,000). The maximum fine for repeat offenders is 10 times as much.
Government officials proposed the changes alongside amendments to the list of indications covered by the legislation. The current law prohibits advertisements intended to lead to the use of products to treat, prevent or diagnose 54 diseases. In revising the law, the government wants to extend the list to cover 78 indications. Proposed additions to the list include AIDS, benign tumors, genetic disorders, leukemias, Parkinsonism and pneumonia.
The draft text is open for comment for 45 days.
Draft Legislation
Malaysia Seeks Feedback on Planned Approach to Refurbished Medical Devices
The Malaysian Medical Device Authority (MDA) has outlined its planned approach to the regulation of refurbished medical devices. MDA created the guidance to help companies comply with rules that require the submission of notifications about refurbished medical devices.
Malaysian law permits organizations to restore used medical devices, for example by replacing worn parts. Organizations that refurbish medical devices are subject to Malaysian rules about the need to register products before they are exported or placed on the market, as well as a circular outlining the requirement for manufacturers to submit notifications to MDA for refurbishment activities.
The draft guidance sets out what information MDA wants manufacturers to include in notifications. Essential information includes details of the company responsible for the refurbished devices, batch numbers for the refurbished products and the manufacturer quality management system certificate. MDA wants companies to submit the requested information via email. 
MDA is accepting feedback on the draft until 19 February.
Draft Guidance
TGA Issues Warning About Products Claiming to Tackle Coronavirus Outbreak
TGA has issued a warning about the inappropriate promotion of complementary medicines for the treatment or prevention of coronavirus. The warning follows the discovery of advertisements that break the laws covering the promotion of therapeutic goods.
In the warning, TGA states it classes advertisements for face masks that claim to prevent the spread of coronavirus and supplements purported to increase immunity as therapeutic use claims. Products sold for therapeutic use typically need to be included in the Australian Register of Therapeutic Goods before they can be sold in the country.
TGA’s warning also highlights some specific points germane to the advertising of products related to the coronavirus. For example, companies need prior TGA approval to refer to coronavirus in ads, either explicitly or implicitly, and must support any claims with appropriate evidence.
The messaging communicated in ads must also be consistent with public health campaigns. That means a face mask cannot be promoted as a “must have” item for people seeking to protect their families from coronavirus as the Department of Health’s position is that they are not necessary for all people.
TGA Notice
Other News:
India’s Central Drugs Standard Control Organization (CDSCO) has extended the deadline for sending applications related to fixed-dose combinations. CDSCO originally asked manufacturers to submit their applications by 22 November. Now, CDSCO has moved the deadline back 30 May. CDSCO Notice


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