Asia Regulatory Roundup: TGA Updates Guidance on the Testing of Biological Medicines

RoundupsRoundups | 23 July 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Updates Guidance on the Testing of Biological Medicines
Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on testing biological medicines. Version 2.0 of the guidance features new details on the use of TGA in-house orthogonal testing methods and other changes.
TGA published the first, and until this week only, version of the guidance in 2015. In revising the guide, TGA has reformatted and updated the text to bring it in line with its current practices, while also adding a new section on the use of the in-house orthogonal testing methods that the agency is increasingly using.
When TGA tests biologicals, it uses its validated in-house methods and internal acceptance criteria based on either the most stringent specifications or an average from approved specifications of the medicines being assessed.
If a product is outside the screening acceptance criteria, TGA retests the drug using pharmacopoeial methodologies, when available, or methodologies and specifications detailed in the certified product details. When using pharmacopoeial methodologies, TGA will use the approved specifications if they differ from the pharmacopoeial standards.
TGA’s response to biologicals that are found to be non-compliant during retesting depends on how badly the product failed the test. Significant failures to critical quality attributes or failures which may have safety implications can lead to a recall and the delivery of letters to doctors about the problems. In contrast, marginal failures lead to lesser penalties, such as warnings from TGA.
TGA Guidance
NPPA Seeks Indian Sales Data on Knee Implants for Price Cap Review
India’s National Pharmaceutical Pricing Authority (NPPA) has asked manufacturers of knee implants to share sales data. The request comes weeks before NPPA is due to review the ceiling prices it set in 2018.
NPPA first capped the price of orthopedic knee implants in August 2017. The imposition of the ceiling prices was intended to drive down the cost of knee implants by around 60%. In August 2018, NPPA decided to retain the ceiling prices for another year, sparing manufacturers from further pressure on the prices they can charge.
With the next price review coming up next month, NPPA has asked manufacturers of knee implants to provide it with commercial data. NPPA wants to know what price implants sell for at multiple points in the supply chain. The agency also requested recent and historic sales volume data.
Those requests apply to all companies that supply knee implants in India. NPPA wants further details from companies that manufacture knee devices overseas for importation into India. Such companies need to supply NPPA with information including the country of origin of their devices and the names of people who hold certain licenses relevant to the importation of the implants.
NPPA wants manufacturers to email it the information by 26 July.
NPPA Notice
India Changes Law Covering Licenses for Certain Manufacturing Clearances
India has changed the law covering the renewal of certain manufacturing licenses. The licenses will remain valid for as long as the holder pays a fee every five years, provided the regulator does not suspend or cancel the authorizations.
The change, details of which were released for consultation last year, covers licenses issued in three forms used by manufacturers of different types of medicines, including large-volume parenterals and vaccines. Core details of the law remain unchanged, but Indian authorities have removed a section that states applications for renewal may cause the licensing authority to conduct an inspection.
Indian authorities have replaced the section that addressed renewal-triggered inspections with text on the duration of loan licenses, which cover manufacturing at third-party sites. As under the old law, loan licenses last five years and are renewed upon application.
The sections on drug manufacturing and loan licenses are largely unchanged from the draft version the government released for consultation last year. However, the government took action elsewhere following the consultation. The document published this week features a new section detailing changes to two forms used by the Central Drugs Standard Control Organization.
Gazette Notification
China Approves GSK’s Lupus Drug Via Priority Review Pathway
China’s National Medical Products Administration (NMPA) has approved GlaxoSmithKline’s Benlysta via its priority review pathway. The approval makes Benlysta the first monoclonal antibody cleared for use in the treatment of systemic lupus erythematosus in China.
GSK and its partner Human Genome Sciences won United States Food and Drug Administration (FDA) approval for Benlysta in 2011, ending a 56-year wait for a new treatment for lupus. Benlysta went on to win approval for lupus in markets including Australia and the European Union, but GSK was slower to bring the drug to China.
The wait for Benlysta to come to China ended this week when NMPA authorized the product after a priority review. NMPA cleared the drug for use in adults, the population covered by the initial FDA approval.
By approving Benlysta, NMPA has furthered its efforts to close the gap between the drugs available in China and the rest of the world. Those efforts have centered on the publication of two lists detailing 78 drugs that NMPA is willing to approve on the strength of a limited dataset. Benlysta is the sort of drug the scheme is aimed at, but the product is not on either of the lists published by NMPA.
Talking to investors in May, GSK CEO Emma Walmsley highlighted the “deregulation that's going on around innovation” in China to explain why the country is “arguably one of the most exciting markets at the moment.”
NMPA Notice (Chinese)
India Bans Use of Colistin Antibiotics in Food-Producing Animals
India has banned the use of colistin in food-producing animals. The government took the action after concluding that use of the antibiotic in such animals is likely to create risks to humans.
Physicians began using colistin in the 1950s, but its true value has only become clear in recent years, when it emerged as one of the few antibiotics that are effective against multidrug-resistant bacteria. The emergence of multidrug-resistant bacteria established colistin as a key, lifesaving medicine, but its utility is threatened by a gene that renders microorganisms immune to its attacks.
European Union officials responded to the situation in 2016 by calling for farmers and veterinarians to minimize the use of colistin in animals. That position reflected the important role colistin plays in humans and the treatment of gram-negative gastrointestinal infections in food-producing species.
Now, India has gone further than the EU. Effective immediately, India has banned the manufacture, sale and distribution of “colistin and its formulations for food producing animals, poultry, aqua farming and animal feed supplements.” All colistin products intended for use in humans must carry a conspicuous label stating they are not for use in food-producing animals.
Gazette Notification
Other News:
The Philippine Food and Drug Administration (FDA) has terminated a voluntary recall of products sold by B. Braun. The company began recalling the suture devices last year after discovering damages to packaging that could have affected sterility. FDA terminated the recall after concluding B. Braun has made reasonable efforts to withdraw and destroy the affected products. FDA Notice
China’s Center for Drug Evaluation (CDE) has released draft recommendations on the implementation of International Conference on Harmonisation guidelines for consultation. CDE is accepting feedback on the recommendations until 19 August. CDE Notice (Chinese)


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