Asia Regulatory Roundup: Clinical Trials in Focus in China, India (2 December 2014)

Welcome to our Asia Regulatory Roundup, a new weekly overview of the top regulatory news in Asia, the Middle East and Oceania.

Industry Questions India’s Readiness for Looming Trial Accreditation Start Date

India is possibly just one month away from introducing a mandatory accreditation scheme for clinical trial sites, ethics committees and investigators, but many significant questions and concerns are still unresolved.

Government officials told The Economic Times the policy will start to come into force early next year — January has previously been targeted — meaning there is little time to finalize preparations. The National Accreditation Board for Hospitals and Healthcare Providers (NABH) is seeking feedback on a draft policy until 15 December, after which it will start work on a final text.

NABH already offers voluntary quality accreditation to healthcare facilities, but some in the industry doubt it currently has the staff for the technical clinical trial audits. “It is a well thought-out plan but will be time-consuming and demand substantial resource investment,” Saurendra Das, executive director of clinical site management business Excel Life Sciences, said.

The Economic Times I NABH Draft

CFDA Posts Draft Guidance on Accepting Multi-Regional Trial Data

The China Food and Drug Administration (CFDA) has released draft guidance on multi-regional clinical trials. CFDA addresses what sponsors must provide before including a Chinese site in a global trial and the conditions that must be met for it to consider the resulting data in regulatory submissions.

China’s large, treatment-naive patient population makes it a popular component of global clinical trial strategies, but the slow pace of regulatory approvals has caused problems. Now, sponsors will at least have a clearer idea of what regulators want. CFDA is asking sponsors to provide it with the dossiers they sent to developed countries.

The draft also clarifies the circumstances in which CFDA will accept data from global trials. Sponsors must run an analysis to show the Chinese subjects enrolled in the trial are representative of the broader patient population in the country. Stringent inclusion/exclusion criteria mean this is rarely the case in any country. Sponsors must also recruit enough Chinese patients to draw valid conclusions.

Mondaq

Maharashtra FDA Warns 23% of Blood Banks After Inspection Spree

The Maharashtra Food and Drug Administration (FDA) has issued notices to 72 blood banks for failing to comply with regulations. Maharashtra FDA posted the warnings after inspecting many of the 309 blood banks in the state at the start of last month, PharmaBiz reports.

Almost one in four blood banks in the state were found to be noncompliant with some aspect of the regulations. The notices are part of a statewide push to ensure the quality of blood reaching patients by improving hygiene practices and staffing levels at the banks. Currently, some of the blood banks are falling well short of what is expected of them by the regulator.

Maharashtra FDA hit Cama Hospital with a stop-operations notice after inspecting its blood bank with the Central Drugs Standard Control Organization (CDSCO). Inspectors reported the blood bank and serology room were “extremely unhygienic” and the facility was operating without a blood transfusion officer (BTO). A 24/7 blood bank is required by law to have three BTOs working in shifts.

PharmaBiz

CFDA Posts Draft Ebola Trial Policy as China Ramps up Preparations

China has stepped up its preparations for the possible arrival of Ebola in the country by publishing a draft policy on clinical trials and the emergency use of diagnostics. The release of the draft coincided with CFDA clearing three companies to manufacture diagnostics for emergency use.

At this stage, the particulars of the policy are unknown. CFDA published a brief notice on the draft policy but gave few details, Reuters reports. The policy will be of particular interest to Sihuan Pharmaceutical, a Chinese company that is developing a treatment for Ebola with the military. In October, Sihuan said it hoped CFDA would shorten typical regulatory timelines for the drug. 

CFDA showed such flexibility during the SARS scare. For now, Ebola diagnostics appear to be more advanced than therapeutics. CFDA has cleared Da An Gene, Shenzhen Pu Rui Kang and Shanghai ZJ Bio-Tech to begin producing Ebola diagnostics so a stockpile is ready for emergency use. With 100,000 Chinese nationals living in Ebola-affected areas, the risk of the virus entering the country is clear.

Reuters

China Proposes Abolishing Price Caps on all Drugs

China is considering a plan to abolish price caps on all drugs beginning in 2015. The proposal comes seven months after authorities lifted the caps on some drugs amid concerns the price ceilings were causing supply shortages and driving manufacturers to cut corners.

The National Development and Reform Commission drafted the policy and sent it to eight industry bodies for feedback, Reuters reports. On the surface, the move away from price capping is a boon for Western drugmakers, some of which have rethought their plans in the country because of tightening margins and other problems.

However, the dominance of China’s hospital network in the procurement of drugs means manufacturers are likely to continue facing pricing pressures even if the caps are scrapped. “We continue to expect very limited impact, since most drugs are sold in hospitals and the pricing is determined by tender process,” Deutsche Bank healthcare analyst Jack Hu said.

Reuters

Other News:

US trade group AdvaMed has welcomed changes to regulation of medical devices in Japan. AdvaMed expects the separation of medical device and drug oversight will help Japan’s Pharmaceuticals Medical Devices Agency to cut the time it takes to approve new products. The law came into force late last month. Press Release

CFDA has proposed changes to 25-year-old regulations for cosmetics. The planned revisions would go some way toward harmonizing regulations in China and Europe, theoretically making it easier for foreign companies to understand and access the country. Specific changes include the classification of oral care products as cosmetics. CosmeticsDesign-Asia

The Gujarat Food and Drug Control Administration (FDCA) is planning to open a medical device testing laboratory. Gujarat FDCA has filed a proposal for the lab, which it argues will help stem the availability of substandard medical devices. The plan is part of a broader rethink of how medical devices are regulated in India. PharmaBiz

The Indian National Security Advisor (NSA) has warned the country is over-reliant on China for active pharmaceutical ingredients. The comments by the NSA are being taken seriously by the government, which has formed a committee to investigate how to boost domestic production. Anti-dumping duties and environmental clearances are among the topics on the committee's agenda. Times of India

Australia’s Therapeutic Goods Administration has said St. Jude Medical’s implantable neurostimulator devices are no longer approved for treating chronic intractable migraines. St. Jude dropped migraines from the list of indications for the device after post-marketing studies failed to replicate the benefits seen in trials. TGA Notice

Indian authorities have ordered Hindustan Antibiotics to stop production. The order follows an inspection by state regulators and CDSCO. Hindustan Antibiotics must revalidate most of its plants and undergo a follow-up inspection before it can resume production. The public company is aiming to resolve the situation within one month. Pune Mirror

Japan's Ministry of Health, Labor and Welfare has cleared InSightec's MR-guided Focused Ultrasound system as a treatment for bone metastases-related pain palliation and advanced uterine fibroids. The approval clears InSightec to expand its portfolio in Japan. Press Release