Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 03 October 2017 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Indian government has ordered Johnson & Johnson and a clutch of other device makers to maintain output of knee implants at pre-August levels. Officials invoked the legislation to stop the companies from cutting production in response to the price ceiling the government brought into force in August.
Invocation of the law means J&J, Smith & Nephew, Stryker, Zimmer and a handful of other implant manufacturers must keep supplying their products in the same quantities as before the cap came into force. The government's action also forces the companies to submit their production figures for the past three years and file weekly reports detailing the number of implants they produce and distribute. All the requirements are in force for six months.
The government’s action follows the playbook it established when trying to stop producers of cardiac stents retreating from the market in the face of a price cap. In both cases, India has turned to powers contained in the Drugs (Prices Control) Order, 2013 to ensure the devices stay on the market despite the squeezed profit margins.
Officials appear to have triggered the supply law to preempt possible shortages, not in reaction to them. The letter makes no mention of requests by manufacturers to withdraw products from the market, nor has local media carried reports of shortages since the ceiling came into force close to two months ago. However, India’s refusal to offer a higher price for what manufacturers see as premium, next-generation implants means industry resistance is a real risk.
That is what happened after the National Pharmaceutical Pricing Authority (NPPA) put a ceiling on the price of cardiac stents. The fallout from that action and the subsequent industry pushback is still being felt.
This week, NPPA revealed Abbott Healthcare has again asked to remove its Xience Alpine brand of cardiac stents from the market. Last time, NPPA rejected Abbott’s request because of faults with its submission and on the grounds it had already invoked the law, forcing the company to maintain output.
This time, with the Department of Pharmaceuticals (DoP) having declined NPPA’s request to extend the six-month forced-supply powers, the cost watchdog found it had “no option but to allow formal withdrawal.” After calculating Abbott can make a profit despite the price cap and assessing the effect of withdrawal on stent availability, NPPA moved to mitigate the impact of the decision by delaying the date on which Abbott can pull the product by one year.
That looked to be the end of the matter. However, two days later the DoP invoked the supply powers and rendered the NPPA’s memo “null and void.” The upshot of the U-turn is Abbott is legally compelled to keep supplying Xience Alpine stents for at least the next three months.
Government Letter, NPPA Memo, DoP Order
The Therapeutic Goods Administration (TGA) of Australia is seeking feedback on planned business process improvements to its complementary medicine assessment pathways. TGA wants to hear the industry's views on its plans to enable the use of overseas regulatory reports to support its pre-market assessments.
Australian regulators are proposing to reform complementary medicine assessment pathways in response to the 2015 expert panel review, most notably by creating a third class of products. TGA has already sought feedback on its plans for that intermediate pathway. The latest request for comment focuses on the evidence, processes and timeframes that apply to these assessments.
One option is to make more use of overseas regulatory reports. To enable this way of working, TGA is proposing to create four application categories. At one extreme are applications processed by TGA on the strength of reports from comparable overseas regulators alone. The other extreme is for applications that require a full de novo evaluation of safety and quality. Applications that fall into the two intermediary groups will feature a mix of existing reports and de novo assessments.
TGA wants to know if the industry agrees with its proposed application categories.
Some of the agency’s other direct questions relate to overseas regulatory reports. TGA also wants to know if the industry agrees with its proposed criteria for assessing the suitability of overseas regulators and determining if the reports they generate are acceptable.
The consultation is part of a planned phased implementation of the new processes. Other steps in this process include a consultation on minimum data requirements, development of forms and guidelines and the creation of a cost recovery impact statement. This last document will support the revised fee structure. TGA also plans to review the proposed fees to ensure they appropriately recover its costs.
TGA is accepting feedback until 7 November.
Australia has opened the door to parallel processing of applications for regulatory approval and health technology assessments (HTA) for certain vaccines. Applicants can benefit from the streamlined process by submitting a filing to the Pharmaceutical Benefits Advisory Committee (PBAC) any time after they have lodged a TGA registration dossier.
Parallel processing by TGA and PBAC could minimize the delay between a vaccine being approved and recommended for listing on the Pharmaceutical Benefits Scheme, a government-subsidized prescription drug program.
The parallel processing option is only open to applications that meet certain requirements. The filing to PBAC must be a major submission, a category that covers applications for approval of vaccines, additions of new indications to existing products and material changes to listed indications.
If this criterion is met, the applicant must lodge a TGA registration dossier before the major submission deadline for the PBAC meeting at which the HTA body will rule on the filing. The filing must include advice from the Australian Technical Advisory Group on Immunisation and address the matters raised by this body.
PBAC will start discussing vaccine applications filed in parallel from its March meeting onward. That gives vaccine manufacturers until next month to lodge major submissions and be part of the first batch of applications considered by TGA and PBAC in parallel.
PBS Notice, Fact Sheet, PBAC Guidance
The Central Drugs Standard Control Organization (CDSCO) has told port offices to stop detaining products awaiting regulatory renewals. CDSCO deems import licenses and registration certificates to be valid provided holders renew by a certain time, but port offices have their own ideas.
The disconnect between the regulations and their implementation centers on rules 28 and 28A of the Drugs and Cosmetics Act, 1940. These state that provided renewal applications are filed within three months of the expiry of import licenses and nine months before the expiry of registration certificates, the clearances remain valid until CDSCO rules on the submission.
Port offices, however, have been detaining shipments of products with licenses and certificates in this regulatory transition window. The Drug Controller General of India Dr. GN Singh has told port offices to stop detaining such shipments.
Singh also used the order to reiterate the deadlines license and certificate holders need to meet if they are to comply with the regulations and avoid problems when importing products.
Tags: Asia Regulatory Roundup, J&J, knee implants