Chinese regulatory Process vastly improved

[lakers]

China has a unique set of demographic, economic and genetic factors that make diabetes an epidemic there; the country is now considered to have the highest rates of this disease in the world, with half the population pre-diabetic. Over the last three decades, China gained economic strength, taking more than 500 million people from poverty and moving much of the country into middle class status but not without effects - more than 7% of the population of 1.4 billion developed diabetes due in part to a diet heavy in carbohydrates and salt, smoking, and inactivity. Worse, Chinese, with a tendency to store fat around the gut, are more susceptible to Type 2 diabetes and develop the disorder at a lower body mass index (BMI) than people of other ethnic origins. Coupled with this, pancreas beta cells, whose job is to store and release insulin, undergo more rapid deterioration with Chinese in early diabetes than those of different race backgrounds. So said, China has a highly vested interest in attacking the disease to uphold ongoing growth and stability.

In an effort to bolster healthcare delivery, Chinese regulatory officials earlier this year issued new drug approval guidelines in hopes to shrink application backlogs and get medicine to more people, sooner. Good for Oramed, clinical study results for ORMD-0801 done elsewhere in the world will count towards approval, a big step for them in China given its lengthy regulatory process. Expedited review will also become available, as will easing of study trial rules. Prior to these positive changes, only drugs approved in other countries could be imported and Chinese patient data only considered in the approval process. All this points to a country where better solutions for diabetes has become paramount.
www.marketwatch.com/story/50-million-plus-royalties-deal-indicates-blockbuster-future-for-orameds-oral-insulin-2015-12-01

[lakers]

China speeds up drug approval process, favoring high-quality generics

China’s Food and Drug Administration (CFDA) recently issued a policy, aiming to shake off its long-term reputation for being extremely slow on new drug approvals, as well as largely improve the quality of Chinese made generics, reports The Pharma Letter’s local correspondent, Wang Fangqing.

Under the policy, which was out on November 11 and took effect immediately, Abbreviated New Drug Applications (ANDA) are in principle reviewed and approved only if they are therapeutically equivalent to their brand-name version. If a brand-name drug is not available in China, the generic version manufacturer has to import it into China to conduct bioequivalence (BE) comparison tests.

Previously, brand-name drugs were preferred, but not necessary as China allowed generic versions to be the reference. One serious result is the poor quality of Chinese-made generics, which “have great difference from the branded version,” according to a 2014 report by the RDPAC, the Beijing based lobbying organization for multinational pharmas in China. In 2009, the CFDA tested the high blood pressure treatment hydrochlorothiazide from five Chinese manufacturers, and had four very different dissolution profiles.

Clinical data fraud

With such a quality issue, perhaps it is not a surprise that clinical data fraud is not rare in China. In late October, the CFDA disclosed 11 ANDAs from eight Chinese manufacturers used fraudulent clinical data. Among them are the hypertension drug candesartan cilexetil tablets from Huahai Pharma, a leading Chinese pharma based in Linhai, Zhejiang province, azithromycin capsules from Yuansen pharma in Hebei province, and ibuprofen suspension drops from Shandong province-based Shandong Dayin Ocean Bio-Pharmaceutical.

The new policy makes it clear that applicants using fraudulent data will be blacklisted and in some cases will be handled to the police for criminal investigations.

To speed up the process for ANDA approvals, the CFDA reviewers now first review the comparative testing results, and reject any application failing to achieve the equivalence without going through other provided documents and testing data.

Also, from December 1, drug manufacturers in China will be able to conduct BE testing without the approval from the CFDA. Since 2007, ANDA applicants have to get two approvals – one for BE testing, one for manufacturing – which largely delayed the process.

The overwhelming amount of ANDAs of already oversupplied generics is another reason for the delay, said a CFDA official. “Companies complain about our low efficiency, but how about they stop filing these low-level ANDAs so we could cut some duplication of work?” he told the Pharma Letter, asking not to be identified.

Most copied drugs

Among the most copied drugs, are cefdinir, atorvastatin calcium and lurasidone, according to the CFDA, which receives about 7,000 new drug applications each year, the majority of which are ANDAs. With only 115 reviewers, it typically takes up to five years for a company to get an ANDA approval, and eight years for an NDA approval. In comparison, the US FDA has about 4,000 reviewers.

The CFDA will soon release a list of the generics oversupplied by multiple manufacturers. ANDAs for these listed drugs, called “category 6 new drugs” in China, will be “suppressed.” The list will be updated regularly.

Price of NDA and ANDA approvals increased

Some measures to discourage such applications have already been taken. In May, the CFDA spiked the price for NDA and ANDA approvals. A company now has to pay 624,000 renminbi ($97,696) for an NDA approval for a Chinese-made drug, and 970,000 renminbi to bring an imported new drug into China, compared with the previous 48,300 renminbi for both. For ANDA approvals, the new price tag is 183,600 renminbi for Chinese-made drugs and 367,600 renminbi for imported drugs, while before companies were only charged less than 20,000 renminbi. The CFDA expects such a prick hike could rebuff low quality applicants.

Meanwhile, the industry watchdog gives priority to ANDAs for drugs in urgent clinical demand, as well as for pediatric and geriatric treatment; NDAs for drugs in areas including oncology, AIDS, rare diseases and major infectious diseases. It also favors the imported novel drugs that will be manufactured inside China.

A draft of detailed requirements for the drugs to receive such priority was released on November 13 for public comments.The deadline is December 13.
www.thepharmaletter.com/article/china-speeds-up-drug-approval-process-favoring-high-quality-generics-by-wang-fangqing