Asia Regulatory Roundup: CFDA Proposes Sourcing Requirements for Drug, Device Companies (3 May 2016)

Regulatory NewsRegulatory News | 03 May 2016 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

CFDA Proposes Sourcing Requirements for Drug, Device Firms as Traceability Agenda Gathers Pace

The China Food and Drug Administration (CFDA) has released another piece of its proposed strategy for implementing a traceability system across the country. In the latest text, the regulator has set out plans to make drug manufacturers assess the quality of their raw material suppliers and keep records relating to their network of sourcing agreements.

CFDA proposed the requirement in a draft document detailing planned improvements to the food, drug and device traceability system in China. The document covers topics applicable to firms in each sector, such as CFDA’s view that manufacturers are responsible for the implementation of traceability systems, and others that are specifically aimed at businesses in the respective industries. The raw material quality proposal, for example, is targeted at the food and drug sectors, both of which have harmed the health of people by failing to effectively monitor suppliers in the past.

Regulatory officials are proposing the adoption of a different set of processes and paperwork in the medical device industry. The device-specific section of the proposal calls for buyers of medical equipment to take appropriate steps to identify their purchases and keep records of their activities. CFDA wants to place the most stringent requirements on Class III devices, those which are deemed to pose the greatest risk to health. Under the proposals, buyers of Class III devices are expected to keep the original data to ensure the traceability of the supply chain. 

CFDA wants buyers of ingredients and finished products to have accurate knowledge of the quality of their suppliers, as well as the paperwork to create an ingredient sourcing audit trail. A lack of such knowledge and paperwork were among the factors that led to the contaminated heparin scandal in 2008, when adulteration with an over-sulfated derivative of chondroitin sulfate was linked to more than 80 deaths. Since then, China has also faced scandals relating to infant milk formula and vaccine quality, both of which have contributed to the recent uptick in regulatory interest in traceability.

In parallel, questions about the appropriateness of Ali Health’s role in the creation and running of the Product Identification, Authentication and Tracking System has driven CFDA to reassess the use of its existing system.

CFDA Notice

India Extends Validity of Medical Device Export Certificates

India has extended the validity of Free Sale Certificates (FSCs) covering medical devices in response to long-standing criticism from the industry. The action ends the need for medical device exporters to seek recertification every two years by instead tying the validity of FSCs to manufacturing licenses.

Now, FSCs will remain valid for as long as a company has a manufacturing license. Prior to the change in policy, the FSCs medical device companies generally needed to export their products were only valid for two years, a lifespan that was seen by the industry as placing an unnecessary bureaucratic burden on its activities. Drug Controller General of India (DCGI) Dr. GN Singh acknowledged the industry opposition to the old way of working in a letter explaining the changes to the country’s state drug controllers.

The change has found favor with the industry. “Extension of validity of the free sale certificate has been a longstanding request to promote exports. The validity period of two years used to restrict registration in overseas countries. It also added to re-registration costs of overseas importers,” Rajiv Nath, secretary of the Association of Indian Medical Device Industry (AIMED) told Business Standard. The cost now stands at Rs 5,000 ($75) per application for an FSC, but companies will not have to pay out repeatedly as in the past.

While the new model addresses one long-standing complaint of the industry, its impact is limited by the restricted definition of medical devices in India. Only 15 medical devices are covered by the Drugs and Cosmetics Act. All other products are unregulated. Certificates to support the export of these unregulated products come from the Directorate General of Foreign Trade (DGFT), not state drug regulators. This has created problems for exporting manufacturers, some of which have found foreign regulators are unwilling to accept the DGFT certificates. 

“Many countries, especially in South and Central America, are not satisfied with this certification. Their authorities desire the certificates be issued by the health ministry or our drug regulatory authority,” Nath said. AIMED wants the government to help companies sidestep this problem by having the health ministry endorse DGFT certificates.

DCGI Letter, Business Standard

China Agrees to Accept Clinical Trial Data Generated at Four Taiwanese Hospitals

China and Taiwan have entered into an agreement regarding the mutual acceptance of clinical trial data. The accord designates four hospitals in China and another four in Taiwan as “bases” for mutual recognition, a status that means data they generate can be used in regulatory filings in both nations.

CFDA’s willingness to accept data from the four Taiwanese hospitals — Taipei Veterans General Hospital, Tri-Service General Hospital, National Taiwan University Hospital and Chang Gung Memorial Hospital — is tantamount to recognition that these sites comply with its regulatory requirements. In granting the sites this recognition, CFDA has opened the door to cross-strait clinical trials that meet its demands for locally generated data.

Regulators in China and Taiwan have been working toward this point for years. In 2014, officials said they had reached a “concrete consensus” on mutual recognition of clinical trial data, an advance that was preceded by a more general agreement to cooperate in the fields of health and medicine. While the current agreement is limited in scale by its focus on just eight hospitals — a number too small to support large clinical trials — it is nonetheless seen as another important cooperative advance.    

History suggests that the liberalization of regional restrictions on clinical trial data can have a notable effect on where studies are run. In the years after Japan expanded the list of countries from which it will accept clinical trial data, the number of studies initiated in China, Taiwan and, particularly, South Korea increased significantly. Taiwan is hoping that the CFDA acceptance of its clinical trial data will support the further expansion of its research sector. 

Focus Taiwan, CFDA Statement, More (both Chinese)

India Revises Track-and-Trace Coding Requirements for Pharma Exporters

India’s DGFT has made further changes to its track-and-trace policy. The latest amendment details how manufacturers should handle barcoding when exporting drugs to countries that have their own specific requirements that are distinct from India’s policy.

In this circumstance, companies are now advised to request exemption from the Indian requirements from the Pharmaceuticals Export Promotion Council of India (Pharmexcil). Pharmexcil will handle the exemption requests on a case-by-case basis “with prior approval of government,” DFGT wrote in the revised text. Regardless of the acceptance of the exemption request, DGFT expects tertiary packaging to comply with India’s policy and, if applicable, the requirements of the importing country.

The new model for seeking exemptions represents a slight revision of the previous approach. As Securing Industry reports, the policy used to advise exporters to submit exemption applications to DCGI. 

DGFT Letter, Securing Industry

Other News:

CFDA has issued a medical equipment quality bulletin. The report follows the testing of 313 batches of equipment, including protective masks and gowns. CFDA Report



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