Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
CFDA Starts Hiring Reviewers as Backlog-Control Strategy Kicks In
China Food and Drug Administration (CFDA) has started recruiting 69 people to help with the review of submissions it receives from biopharma companies. The hiring coincides with attempts by CFDA to bring its ever-growing backlog of applications under control.
CFDA is looking for candidates with a range of capabilities. If the hiring goes as planned, CFDA will add reviewers versed in biostatistics, toxicology, Chinese medicine and other fields to its workforce, improving its ability to conduct thorough and timely assessments of the submissions it receives. The strengthening of the workforce is one of several ways in which CFDA has moved to get on top of its backlog over the past month.
Another of the initiatives has started to pay off. The deadline for the self-audit and authentication of clinical trial data by organizations waiting for CFDA to review their submissions passed in late August. A few days after the deadline, CFDA released figures showing that the self-audit requirement led to the withdrawal of 317 filings. Self-audit reports were submitted for two-thirds of filings reported on by CFDA in its release.
CFDA Hiring Statement (Chinese), CFDA Self-Audit Notice (Chinese)
Indian Advisory Board Refuses to Rule on PET Bottle Ban
India’s Drug Technical Advisory Board (DTAB) has refused to make a ruling on the ban of bottles made of polyethylene terephthalate (PET) in pharmaceutical packaging. DTAB has asked members of the government to review the situation in light of the findings of recent studies, PharmaBiz reports.
The refusal by DTAB to make a decision means the uncertainty over the long-term legality of PET bottles is set to continue. Efforts to ban the material began in earnest nearly one year ago when the government published an amendment to the Drugs and Cosmetics Rules. The notification prompted a backlash from PET packaging manufacturers and drugmakers, groups that have argued the material is safe and that India lacks the glass production capacity to cope with the ban.
DTAB had previously sided with those trying to ban the use of PET. At a meeting in November 2013, the board recommended a phased withdrawal of PET, starting with a ban on its use for products aimed at pediatric and pregnant populations. Since then, the idea has faced criticism and DTAB now wants the government to look over the findings of a study by the All India Institute of Hygiene and Public Health. The study led to calls for a large-scale investigation into cumulative exposure.
China Fines Pfizer over Promotion of Viagra in Drugstores
Authorities in China have punished Pfizer after ruling the company paid drugstores RMB 930,000 ($145,700) to recommend and display Viagra. The punishment includes the confiscation of RMB 3.0 million ($470,000) Pfizer allegedly made as a result of the deals and a fine of RMB 100,000 ($15,600).
The case relates to deals Pfizer reportedly signed with four drugstores in Shanghai from 2011 to 2013, according to China Daily. Authorities claim the drugmaker paid RMB 930,000 to the stores in return for commitments about the display of its erectile dysfunction blockbuster, Viagra. The terms of the deals made the shops describe Viagra as a recommended product and secured it a prominent position on the shelves. The quantity of products and space occupied were fixed in the deals.
Such arrangements between biopharma companies and drugstores are prohibited by law in China. Pfizer has accepted its punishment and committed to improving its operations. “Due to some lapses in supervision, the display agreements were not executed accurately in these pharmacies. We have already incorporated improvements in our policies and practices related to pharmacies, to ensure that we comply with all laws that apply to our business activities,” a representative said.
China Daily, FiercePharma
India Advances Plan to End Duplicated Testing of Drugs on Animals
DTAB has recommended a change to animal testing requirements in India. The proposal would end the need for developers that have already generated toxicology data on their products for other markets to repeat the tests to satisfy India’s Central Drugs Standard Control Organization (CDSCO).
Changes to the law have been in the works since a government minister pointed out that India’s links to the Organisation for Economic Cooperation and Development mean it is obliged to accept data generated in certain other countries, The Asian Age reports. The actions by the minister led to a review of the situation by the Investigational New Drug Committee, which then passed the matter on to DTAB.
Both bodies have backed a scaling back of the testing requirements. DTAB has recommended that the submission of authentic toxicology results alongside the technical data absolves companies from the need to run any further tests on animals. The proposed tweaking of the rules is part of a wider move in India to cut the use of animals in testing. As part of the move, India recently banned the importation of cosmetics tested on animals.
The Asian Age
The New Zealand Medicines and Medical Devices Safety Authority has changed its guidelines on pharmacovigilance in response to feedback. GlaxoSmithKline, Pfizer and Roche are among the firms to have submitted feedback to the regulator, leading to it making tweaks and adding new sections to edition 2.0 of its 36-page pharmacovigilance guidelines. Feedback, Guidelines
CFDA has adopted 130 national standards for materials used in drug packaging. The standards cover drug packaging materials that come into direct contact with the product, such as infusion bottles made of soda lime glass, and establish quality control specifications and test methods. CFDA is to implement the standards from 1 December. CFDA Notice (Chinese)
Bangladesh Directorate General of Drug Administration (DGDA) is looking for an online reporting system to support its attempts to control and monitor counterfeit products, medicine overpricing and adverse drug reactions. The release of the request for expressions of interest (EOI) coincided with the start of a clampdown on the sale of banned products. EOI, The Daily Star
CDSCO has struck a deal to use UL EduNeering to train its inspectors and regulators. The deal to use the e-learning system, which was developed with the United States Food and Drug Administration, has been discussed for months. UL first made inroads into the Indian regulatory sector in January when it entered into a memorandum of understanding with the state of Gujarat. Press Release
The Indian government is nearing the finalization of its plans to improve the local medical device sector. “The important hurdle is the regulatory mechanism. The duty structure has to be modified. Probably by next week, we will finalise the recommendations,” VK Subburaj, a secretary in the Department of Pharmaceuticals, said. Press Trust of India
The Secretary of the Department of Health can now cancel medical devices from the Australian Register of Therapeutic Goods (ARTG).The clarification of the cancellation process for medical devices and in-vitro diagnostics follows a review by the Therapeutic Goods Administration (TGA). TGA will publish details whenever such a cancellation occurs. TGA Notice
Officials from the National Institutes of Health (NIH) have visited Gujarat Food and Drug Control Administration (FDCA) to assess the feasibility of its plans to set up a medical device testing lab. PharmaBiz