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Regulatory News | 07 November 2017 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The China Food and Drug Administration (CFDA) has moved to strengthen oversight of online sales of drugs and medical devices. CFDA outlined its plans in a notice instructing its regional outposts to step up their monitoring of the internet and make it easier for the public to alert them of illegal activity.
Regulatory officials laid out their strategy for stopping illegal sales of drugs and medical devices in a seven-point memo to the regional offices of CFDA. The memo tasks CFDA staffers with making enterprises with online activities key inspection targets and creating mechanisms for investigating the illegal trade of drugs and medical devices over the internet.
CFDA expects its officials to use the internet effectively themselves to gather information and keep the public aware of the risks of buying health products online. In terms of data gathering, this means ensuring it is as easy as possible for people to provide information about online drug sales, either via the internet or telephone. CFDA expects local officials to use popular social media sites such as Weibo and WeChat to share information with the public.
Officials at the state level will monitor the implementation of these orders.
As with many of CFDA’s recent actions, the publication of the plan follows an order from central government. The order came late in September when the government included online drug sales in a wide-ranging set of reforms. At the time, the government told CFDA to create a mechanism for monitoring online sales, simplify the whistleblowing process and create a “black list.” The order also tasked CFDA with severely punishing organizations found to sell drugs online illegally.
CFDA Notice, Government Order (both Chinese)
The Central Drugs Standard Control Organization (CDSCO) has told its port offices to stop holding up the importation of medical devices on certain technical grounds. Port officials should now allow the importation of products covered by valid certificates and licenses even if some of the details on the consignment differ from other records.
CDSCO sent out the memo after learning of three issues that are stopping medical devices and in vitro diagnostics from proceeding smoothly through ports. Some medical devices are being held up by slight differences between the names on consignments and on certificates and licenses. Other devices are getting stuck because the license holder is in the process of changing their details after a merger or acquisition. Finally, different expiry dates in multicomponent kits are causing delays.
Joint Drugs Controller Dr. VG Somani wants ports to show flexibility when it is clear the importer and consignment are valid and supported by the appropriate clearances. In the case of confusion about names, Somani told ports to allow imports through if the authorized person shows the devices are covered by the registration certificate, despite the superficial differences.
Somani is proposing a similar model for devices owned by companies that are going through a merger. Provided the courts or competent authority have endorsed the changes necessitated by the merger, the port should release the consignment.
The final scenario covered by the memo is different. The problem in this case arises from the inclusion of components with different expiry dates in multicomponent kits. Somani wants port officials to use the component or reagent with the “lowest expiry date” in calculations of shelf life.
Publication of the memo comes one month after the Drug Controller General of India (DCGI) told ports to stop detaining products covered by import licenses and registration certificates that are in the process of being renewed.
Australia’s Therapeutic Goods Administration (TGA) will expand its automated notification process to cover prescription drugs next month. The expansion comes months after TGA began allowing manufacturers of over-the-counter (OTC) medicines to make minor changes using the online form.
TGA expects to start accepting notifications from makers of prescription drugs on 4 December. The agency will spend the three preceding days preparing its IT systems for the go-live date. Over that period, TGA will restrict the ability of prescription and OTC drug companies to submit new changes or edit existing drafts.
The work is intended to usher in a more risk-based approach to the management of variations to registered drugs, a change recommended in the expert review of Australian regulations. Under the scheme, companies can apply to make changes that will not affect quality, safety or efficacy using an automated online system. Once the company has filed a request, made legal assurances and paid a fee, TGA will automatically approve the change and update its records.
Examples of the types of changes allowable under the automated scheme include revisions to batch sizes, implementation of new in-process control tests and deletions of manufacturing steps. Even these changes can only use the scheme if certain conditions are met. TGA also states what information companies must provide for each type of change to be processed under the new system.
DCGI Dr. GN Singh has released a list stating how India will classify medical devices once new rules come into force at the start of next year. The 247-item list covers the category, name and risk class of different medical devices and IVDs, plus a brief description of their intended use.
India, like Canada, the European Union and other territories, is implementing a four-tier system for classifying medical devices. The list shows high-risk devices, such as those used in the ablation of tumors, will go into Class D. India is putting the lowest-risk devices, including Y-connectors used to connect perfusion sets, into Class A.
Publication of the list comes two months before the implementation of the Medical Device Rules, 2017, legislation that will end India’s long wait for a distinct, comprehensive framework covering devices and diagnostics.
The list shared this week is dynamic, and as such will undergo changes from time to time.
Pakistan is pushing ahead with plans to require 2D barcodes on the packaging of medicines. The barcodes are part of the Drug Regulatory Authority of Pakistan’s (DRAP) attempt to crack down on fake drugs.
DRAP signaled its intent to require 2D barcodes in a notification published over the summer. Now, in statements to local media published on its website, DRAP has confirmed the requirements will come into force on 15 December. After that, manufacturers must emboss barcodes that follow guidelines set by international standards organization GS1 on their products.
Officials also expect companies to maintain a database covering the barcodes of their products and share the resource with DRAP. The agency will link these resources to its Drug Regulatory Information System, an online portal. DRAP is holding training sessions intended to ease the technical challenges of transitioning to the new system. The regulator held the first of first of these sessions late last month.
Once in place, the system will provide a way to confirm the authenticity of products and track their path through the supply chain.
DRAP News, Securing Industry
Tags: CDSCO, device imports, online drug sales, Pakistan