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Posted 15 December 2015 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, a weekly overview of the top regulatory news in Asia.
Fresh Batch of Withdrawals and Rejections Chips Away at CFDA Backlog
China Food and Drug Administration (CFDA) has wiped almost 150 drug filings from its backlog. Most of the applications were pulled by the companies themselves, with CFDA only actively rejecting 13 of the submissions.
The withdrawals affected 131 filings by 82 companies. CFDA put pressure on companies to take a critical look at their own filings and the data supporting them when it initiated a self-audit process earlier this year, leading to many organizations pulling their applications. At the start of this month CFDA said 62 companies had withdrawn filings covering 87 medicines, numbers that had swelled to 82 and 131, respectively, by 14 December.
Companies that opt to keep their applications in the queue are being scrutinized by CFDA. Officials at the regulator rejected another 13 applications, all of which were submitted by local companies, this week after reviewing the documents. The filings, which covered therapeutics to treat depression, cardiovascular diseases and other conditions, were rejected for a range of reasons. CFDA went over its reasons in a release to reveal the rejections.
Data manipulation was a recurring theme. CFDA criticized a filing for a sustained-release formulation of aspirin for selective use of data. Having tested a batch twice and generated two notably different results, the company picked one set of data without explaining its reasoning. In total, nine of the 13 applications were criticized for selective use of data. Modification and, in one case, falsification of data were also observed by CFDA reviewers, prompting the rejection of the submissions.
The removal of the applications continues CFDA’s attempt to whittle away at its backlog, which has grown to an unmanageable size in recent years. With 18,000 filings in the queue as of the last count, CFDA is still some way from getting on top of the problem. The simultaneous elimination of a subset of filings that are of poor quality, discouragement of the submission of further subpar applications and hiring of 69 people to perform reviews could move CFDA in the right direction, though.
CFDA Notice, More (Chinese)
Indian Trade Association Bemoans Patchwork of State and National Regulators
The Associated Chambers of Commerce and Industry of India (Assocham) has cited the patchwork of national and state-level regulators as a problem for pharmaceutical companies. Assocham made the statement after working with research firm RNCOS to assess the state of the local industry.
As it stands, companies operating in India must interact with multiple bodies. With the Central Drugs Standard Control Organization (CDSCO), Drug Controller General India (DCGI), zonal offices and state Food and Drug Administrations each having a say in aspects of the regulatory process, Assocham thinks the system is unnecessarily complex and burdensome. “[It] makes the process of obtaining license for pharmaceutical product manufacturing complex,” the trade association wrote.
Assocham sees the complexity replicated in the patent system. With patent offices operating out of multiple cities in India and, in the view of Assocham, following their own individual practices and lacking central controls, the model is seen as encouraging inconsistency. “These varied practices and poor centralized controls affect the quality of the pharmaceutical products,” Assocham wrote. The trade group is also concerned about variability in the knowledge and training of pharmacists.
The main concern for Assocham is how these inefficiencies affect trade. Assocham is particularly worried about how regulatory staffing levels are affecting exports. The trade group calculates India has 1,500 well-equipped inspectors for more than 10,000 facilities, figures it sees as leaving local firms ill-prepared for the demands of foreign regulators. “We need to get our own house in order by way of continuous skilling of the regulators,” Assocham Secretary General D S Rawat said.
CDSCO Simplifies Paperwork Needed to Export Drugs, Devices to Established Markets
CDSCO is to allow companies to export drugs and medical devices to some established markets without obtaining a “no objection certificate.” The policy, which will come into force on 1 January, affects exports to the United States, the European Union, Canada, Japan and Australia.
Adoption of the new policy will remove one of the bureaucratic hurdles to exporting drugs and devices from India. The process of obtaining a certificate forces manufacturers of finished dosage forms to provide details of their operation and the identity of their active pharmaceutical ingredient suppliers before they can export products. Now, CDSCO is eliminating this process for exports to some countries “to bring ease in the drug regulatory practices in India related to exports of drugs.”
The move effectively shifts the burden of gathering details of a manufacturing operation from CDSCO to regulators in the US, EU, Canada, Japan and Australia. In its notice to reveal the new policy, CDSCO reiterated the need for exporters to comply with the regulatory requirements of the countries to which they ship products. The nations affected by the policy are better equipped than most countries to keep track of imports of drugs and medical devices.
Merck, Samsung Win Approval for Remicade Biosimilar in South Korea
The Ministry of Food and Drug Safety (MFDS) in Korea has approved Merck and Samsung Bioepis’ biosimilar copy of Johnson & Johnson’s blockbuster immunology drug Remicade. MFDS has now approved two immunology biosimilars developed by the Merck-Samsung collaboration.
Merck plans to introduce the biosimilar, named Renflexis, in the first half of next year, at which time it will have two biological copycats on the market in Korea. The roll outs of copies of Remicade and Amgen and Pfizer’s Enbrel represent early breakthroughs for the collaboration between Merck and Samsung. Having teamed up in 2013, the partners have set about developing biosimilar versions of Remicade, Enbrel, Humira, Herceptin and Lantus with a view to winning approvals around the world.
MFDS, which oversees Samsung’s home market, is among the first regulators to give its approval to the biosimilars. Last month, the European Medicines Agency recommended a copy of Enbrel from Samsung and Biogen, another of the Korean conglomerate’s collaborators, for approval. The allies are also developing a copy of Remicade for the European market. Copies of Herceptin, Humira and Lantus are in late-phase development.
CDSCO has clarified the regulatory requirements for bulk imports of suture reels. Companies that have valid production license for sutures and are importing the reels for further manufacturing do not need to apply for a registration certificate before bringing the products into the country. Import licenses and registration certificates are needed if the buyer is a hospital. CDSCO Notice
CFDA has posted another document about its burgeoning collection of medical device regulatory texts. The latest update provides an overview of changes proposed to date and how they relate to medical device testing institutions. CFDA has spent the past year overhauling its approach to the oversight and regulation of the medical device sector. CFDA Statement (Chinese)
Authorities in Bangladesh have detained two physicians over the alleged production of spurious drugs. After the Directorate General of Drug Administration (DGDA) of Bangladesh raided the facility in collaboration with the police, the physicians presented a certificate to prove the legitimacy of the operation. “The certificate was forged,” a DGDA official said. bdnews24.com
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe)has published the December edition of its update to physicians. Prescriber Update
Tags: CFDA, CDSCO, Korean biosimilars, drug applications