Asia Regulatory Roundup: China’s NMPA Steps up Oversight of Epidemic Prevention and Control Products

RoundupsRoundups | 28 January 2020 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China’s NMPA Steps up Oversight of Epidemic Prevention and Control Products
China’s National Medical Products Administration (NMPA) is encouraging its regional outposts to step up their oversight of manufacturers of products intended to prevent and control epidemic infections. NMPA’s statement comes as a deadly coronavirus spreads across China.
The threat posed by the coronavirus creates the potential for noncompliance at the manufacturers of products to diagnose, treat or prevent infections, either because legitimate teams are overstretched or unscrupulous players are seeking to cash in on consumer concerns. NMPA wants officials to take steps to ensure products made to address the threat comply with the normal standards.
Specifically, NMPA is asking local drug regulatory authorities to strengthen supervision of companies involved with antivirals, protective masks and clothing, in-vitro diagnostic agents and other products related to the management of epidemics. NMPA wants officials to carry out random inspections of such companies, as well as urge them to comply with quality management standards and ensure that their drugs and devices can be traced.
NMPA issued the statement the day after revealing it has approved four nucleic acid reagents for use in the detection of coronavirus. The reagents were approved under the emergency measures NMPA put in place at the start of the outbreak. NMPA plans to continue using the emergency approval procedures to fast track the progress of products designed to manage the epidemic, while relying on the additional oversight to ensure quality and safety once the drugs and devices are on the market.
NMPA Notice, More (both Chinese)
Big Pharma Trade Group Pushes TGA to Rethink Approach to Online Information
Medicines Australia has found fault with all proposed changes to how information about excipients is shared online. Australia’s Therapeutic Goods Administration (TGA) responded to the feedback from the big pharma trade group and other organizations with a policy it thinks is a compromise between the positions of different stakeholders.
TGA ran a consultation last year to gather feedback on potential ways to enable consumers to access more information about the excipients used in medicines. The basic idea was to add the information to the Australian Register for Therapeutic Goods (ARTG) so consumers can find out if a drug contains allergens. However, TGA’s desire to also respect trade secrets led it to propose compromises that fell short of full transparency. 
Medicines Australia, a trade group representing large pharmaceutical companies, wants TGA to make changes to how information is accessed by consumers but questioned whether simply publishing the names of excipients on the ARTG will achieve that goal. The questioning is underpinned by analysis of how consumers look for allergen information and the level of lay knowledge of excipients.
“Medical information requests are made to obtain confirmation as to whether a product contains a particular allergen e.g. gluten; lactose; egg etc. which may derive from the use of excipients containing these components. It may thus be difficult for consumers to link the list of excipients on the ARTG to the allergen they are seeking to avoid. Similarly, use of scientific rather than common names in the ARTG may also limit the usefulness to consumers,” the trade group wrote.
Medicines Australia also questioned whether the ARTG is the right place to share lists of excipients, stating that, “There is a general lack of awareness,” of the resource among consumers. In light of the perceived flaws with TGA’s approach, Medicines Australia called for further talks to figure out the best way to get information to consumers.
Having gone through the feedback, TGA has come up with a final proposal that hews closely to the approaches criticized by Medicines Australia. TGA plans to list “excipient names in the public view of ARTG entries for medicines.” Excipients found in proprietary flavor, fragrance and color combinations will not be named. Rather, the ARTG will just state whether a proprietary mix is present.
TGA’s plan is in line with the proposal favored by drugmakers including AbbVie and Pfizer, although the latter shares Medicines Australia’s doubts. The final proposal avoids one of Medicines Australia’s concerns, though, by ensuring full disclosure of proprietary information is not required. The trade group argued that level of transparency “would make copying easier by competitors.”
The finalization of the plan will enable TGA to move on to the next steps in the process. Before TGA can publish excipient information in the ARTG, legislative and IT changes need to happen. TGA aims to complete the IT changes in the first half of 2020.
Consultation Responses
India’s CDSCO Publishes List of Drugs Covered by Bioequivalence Study Rules
India’s Central Drugs Standard Control Organization (CDSCO) has published a list of drugs covered by its rules on molecules in category II and IV of the Biopharmaceutics Classification System (BCS). The list is intended to help developers of generic medicines.
In 2017, CDSCO issued a notice calling for developers of BSC II and IV medicines to submit the results of bioequivalence studies alongside their applications for oral drug licenses. The requirement set the drug regulator up to see data on the bioequivalence of low-solubility generic drugs to their reference products at the time it reviewed filings for licensing.
Since then, CDSCO has taken a series of steps designed to help companies affected by the rules, for example by providing training on the conduct of bioequivalence studies of Class II and IV medicines. The list published this week is the latest step in CDSCO’s support agenda.
CDSCO’s list identifies 139 molecules that fall into category II or IV of the BCS, signifying they have low solubility. In each case, CDSCO states whether the molecule is class II or IV, indicating whether it has high or low permeability, respectively, and lists the companies involved in its manufacture and sale in India. CDSCO will add more drugs to the list in the future.
Developers of generic drugs can use the list to learn whether a molecule is subject to the rules on BCS II and IV medicines and identify the product against which they must compare their off-patent copy. CDSCO wants companies to compare generics to the relevant innovator’s reference product. If that is not possible, CDSCO will accept comparison against an approved Indian reference product.
CDSCO Notice
Philippine FDA Issues Guidance on Medical Device Authorizations
The Philippine Food and Drug Administration (FDA) has published a circular on the authorization of medical devices. The document covers the use of the Association of Southeast Asian Nations (ASEAN) harmonized technical requirement.
In 2018, the Philippines published guidance on the alignment of the country with ASEAN standards and the resulting requirements for authorization of medical devices in the country. The new notice builds on that earlier guidance by providing information on the classification of devices by the risks they pose and application fees.
An annex to the circular lists more than 100 types of medical devices. FDA has assigned each type, or subtype, of device to a risk category ranging from A, low risk, to D, high risk.
FDA Circular
Other News:
China’s Center for Drug Evaluation (CDE) has entered into a collaboration with Shenyang Pharmaceutical University. The agreement is intended to support the reform of the drug approval and review system by encouraging cooperation between the two organizations. CDE Notice (Chinese)


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