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Asia Regulatory Roundup: Shanghai FDA Expands Medical Device Registration Pilot

Posted 10 July 2018 | By Nick Paul Taylor 

Asia Regulatory Roundup: Shanghai FDA Expands Medical Device Registration Pilot

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
 
Drug Industry Calls for TGA to Apply Efficacy Claimers to Prescription Medicines
 
The Therapeutic Goods Administration (TGA) is under pressure to apply its proposed efficacy claimers to all medicines that undergo pre-market assessments of their effectiveness. TGA proposed to allow manufacturers to use the claimers on some types of non-prescription drugs, but groups including Medicines Australia want the agency to broaden the scope to avoid confusion.
 
Officials at the Australian regulator came up with the efficacy claimer idea in response to a proposal to create an assessed listed pathway. TGA will assess the efficacy of products that follow this pathway, but leave manufacturers to self-certify safety and quality. Given the pathway entails more work than the current route to market for vitamins and herbal medicines, TGA proposed allowing companies to make efficacy claims. This privilege is intended to incentivize companies to use the pathway.
 
However, providing this privilege to assessed listed products would give them an advantage over registered complementary medicines and over-the-counter products, which face similar or greater regulatory burdens. TGA therefore proposed allowing all pre-market assessed, non-prescription medicines to make claims, but this broad application of the idea still excludes prescription drugs.
 
Pharmaceutical trade group Medicines Australia thinks the exclusion of prescription drugs is a problem.
 
“The claimer should be used on all medicines that successfully pass TGA pre-market assessment of efficacy, including prescription medicines,” Medicines Australia wrote. “Consumers will be reassured that their prescription medicines have also had appropriate scrutiny for safety, quality and efficacy, preventing consumer misunderstanding which may result in decreased adherence to their prescribed medicines.”
 
Applying efficacy claims to products assessed under multiple different pathways will create further complexity, though. Medicines Australia brought up this concern in its response. The trade group wants the efficacy label claims to reflect the pathway the product followed to approval. This would mean having different labels for assessed listed products, registered complementary medicines, over-the-counter products and prescription drugs.
 
Medicines Australia thinks such distinctions are essential to the success of the efficacy claimer idea. However, as the trade group notes, this could be confusing for consumers. Medicines Australia is concerned that consumers have low individual health literacy and, as such, may struggle to understand the label claims. If the label claims only apply to non-prescription medicines, this could lead to the erroneous assumption that they have undergone a more rigorous assessment than prescription products. If all pre-approved products carry efficacy claims, the trade group thinks an educational campaign will be needed to educate consumers about the differences.
 
TGA typically responds to the feedback submitted to its consultation when it publishes the comments online. However, TGA published the feedback to the efficacy claimer consultation without providing its responses to the comments. TGA plans to publish the outcomes of the consultation “in due course.”
 
Medicines Australia, All Submissions
 
Japan Creates Guidance for Managing Medication of Elderly Patients
 
Japan has created guidance on managing the medication of elderly patients, particularly people aged 75 years and older. The document is intended to mitigate the adherence and polypharmacy problems that can arise when managing the health of seniors.
 
Around 35 million people — 28% of the total population — in Japan are aged 65 years or older. That predominance of senior residents makes it particularly important that Japan has access to medicines tailored to the needs of elderly patients, and that its healthcare professionals understand how to use these products.
 
To support these goals, Japan’s Ministry of Health, Labour and Welfare (MHLW) has created guidance on appropriate medication for elderly patients. The guidance is aimed at healthcare professionals, specifically physicians, dentists and pharmacists, but its enactment will have implications for drug companies.
 
One readthrough for drug companies relates to MHLW’s guidance on how to ensure seniors comply with their treatment programs. MHLW is encouraging healthcare professionals to make it easier for seniors to comply by reducing the number of drugs they have to take, suggesting there is a market opportunity for products that combine commonly co-prescribed therapies. The health ministry also highlighted “dosage form selection” and “simplification of use” as ways to mitigate the problem.
 
MHLW is also seeking to discourage the use of certain drugs in seniors. For example, the guidance advises against using long-acting benzodiazepines in seniors, as these patients may be more sensitive to the molecules and less able to metabolize them. The English language translation of the guidance from the Pharmaceuticals and Medical Devices Agency (PMDA) only features a snippet of MHLW’s advice on drug selection. In the Japanese text, MHLW covers 12 classes of medicines.
 
PMDA Translation, MHLW Guidance (Japanese)
 
CDSCO Creates Veterinary Regulatory Cell to Handle Approvals, Import Requests
 
The Central Drug Standard Control Organization (CDSCO) has created a veterinary cell to manage regulatory processes related to animal medicines. CDSCO’s seven-person unit will handle marketing authorizations, imports and registrations, field trials and other tasks.
 
Other tasks assigned to the cell include no-objection certificates related to veterinary medicines and vaccines, the testing of veterinary biologicals, the use of antimicrobials and matters related to oxytocin. The oxytocin-related responsibilities put the cell on the front line of Indian efforts to curb misuse of the hormone, which dairy farmers have used to boost milk production.
 
CDSCO has assigned one member of the team, AK Pradhan, specifically to assist with matters linked to the misuse of oxytocin. The other six members of the cell have broader responsibilities. Bangarurajan, a joint drugs controller, is the most senior member of the team.
 
The cell was formed on 3 July, the day CDSCO published details of its existence.
 
CDSCO Circular
 
Shanghai FDA Expands Medical Device Registration Pilot to Cover Whole City
 
The Shanghai Food and Drug Administration (SHFDA) has expanded a medical device registration pilot project to cover the whole of the city. SHFDA initially limited the pilot to a free trade zone, but is now expanding the initiative in response to feedback from medical device manufacturers.
 
City officials began the pilot program late last year. Since then, SHFDA has approved six Class II medical devices under the provisions of the pilot program. Medtronic is among the companies to get medical devices registered through the pilot project. More than 20 other companies are preparing to participate in the pilot, which is set to expand to include higher-risk Class III medical devices.
 
Trade group the China Association for Medical Devices Industry (CAMDI) thinks the initiative has brought benefits. In a statement about the expansion of the pilot, CAMDI said the pilot has optimized resource allocation and promoted the division of labor between R&D and production.
 
CAMDI also thinks the pilot is encouraging local production of medical devices developed by multinational companies, such as Medtronic. The medical device giant is relying on Jabil’s Shanghai operation for the production of a surgical power system. CAMDI thinks this will drive down the cost of medical devices in the city.
 
SHFDA Notice, CAMDI Notice (both Chinese)
 
Other News:
 
The New Zealand Medicines and Medical Devices Safety Authority has cleared Sanofi to import the Hong Kong version of antipsychotic Neulactil to deal with a temporary shortage. Sanofi encountered the supply problem while changing the drug’s manufacturing site. Sanofi Notice
 

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