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Posted 03 February 2015 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China Food and Drug Administration (CFDA) has named Bi Jingquan as its new leader, ending Zhang Yong’s two-year stint in charge of the regulator. Bi trained as an economist in the late 1970s and has since held a string of pricing-related positions.
The appointment of a pricing expert has prompted speculation Bi is being tasked with leading the next set of negotiations with pharma companies. Much of his pricing experience was gained outside pharma — particularly in the agriculture sector — but his scope has broadened in recent years.
In 2007, Bi called for the restructuring of drug pricing to ensure the affordability of healthcare, FiercePharma reports. The topic has become more pressing and pertinent over the past eight years.
FiercePharma I Xinhua(Chinese)
The Drug Regulatory Authority of Pakistan (DRAP) finally has a CEO. After a two-year recruitment process, Dr Muhammad Aslam has joined the regulator as CEO and put drug pricing and quality at the top of his agenda.
Both issues could cause Aslam headaches in the coming months. The development of a pricing policy has taken as long as the search for a CEO, and arguably been less successful. Authorities are yet to hit upon a model that is acceptable to industry, which has more than 10 active pricing appeal cases in front of DRAP. The current plan is to tie the price of drugs to the averages in Bangladesh and India.
Aslam will need to find a way to end the impasse while also making improvements to DRAP. Corruption is one of the problems. The controversial decision to shortlist Aslam and another member of the drug industry over four public sector candidates was reportedly related to corruption allegations against the government officials.
Licenses, prices and building leases are all allegedly influenced by corrupt groups. Some fear Aslam’s naivete in these areas could actually be a hindrance. “As Dr Aslam is from the private sector, it will take him some time to understand the issues at DRAP. It is feared that he will be manipulated by the mafia before he becomes aware of the issues,” an anonymous ministry official told DAWN.
Sen. Haji Ghulam Ali voiced different concerns about the appointment, which he considers illegal. Ali is worried Aslam — who worked at Otsuka Pharmaceutical — will favor multinational companies over local drugmakers.
DAWN I Business Recorder I More
The Drug Controller General of India (DCGI) has tasked regulators in the country’s northeastern states with more stringently enforcing good manufacturing practices (GMPs). Bihar and Rajasthan are among the states targeted by the strategy, which includes a continuation of the sampling initiative DCGI has already applied in other regions.
Officials have so far taken 60 samples from public healthcare centers and pharmacies in Rajasthan. The random sampling is intended to encourage manufacturers and state regulators to pay closer attention to GMPs, a scenario that would cut the prevalence of substandard manufacturing operations such as the ones discussed in the wake of the Chhattisgarh sterilization deaths.
“It will be an ongoing exercise in coordination with state drug regulators to enhance enforcement for arriving at drug quality. The exercise would sensitize state drug regulators in enforcing GMP standards more stringently,” DCGI Dr. G. N. Singh told PharmaBiz.
The Chinese Pharmacopoeia Commission (ChP) and Waters have opened their joint laboratory. ChP will use the lab to research pharmacopeia standards and develop testing methods in an attempt to ensure drug quality and protect public safety.
ChP has operated in some form since China first published a compendium of drugs in 1950, but the opening of the lab comes at the start of a new phase in its history. Having been housed in the Ministry of Health for much of its history, ChP is now part of the recently revamped CFDA.
The 400-square-meter lab forms part of how ChP will implement its evolving role. ChP expects the lab to join a network of technical support centers tasked with maintaining pharmaceutical standards in China.
CFDA has outlined its plan to strengthen the regulatory inspection process and improve food safety. The proposals follow a period in which the challenges of regulating a large, fast-growing country and its fragmented supply chains have become increasingly apparent.
Authorities have responded to food and drug safety scares by calling for a strengthening of inspection infrastructure at the local, regional and national levels. An increase in inspection capacity and more rigorous training are among the proposals, which also call for greater information sharing and a more coordinated approach.
The financing and implementation of the strategy could prove problematic, but Chinese officials are conscious the current shortcomings could harm the country. Officials listed the improvement of food safety as a priority for 2015.
CFDA Notice (Chinese) I Reuters
India’s Central Drugs Standard Control Organization (CDSCO) is set to codify the pre-submission meeting initiative it has run in recent years. The proposal follows pressure from drug developers. “Stakeholders feel that there should be a window for technical deliberations with the regulator and subject experts before submission of formal application,” an official told The Times of India. TOI
Australia’s Therapeutic Goods Administration (TGA) has warned consumers about counterfeit versions of Eli Lilly’s erectile dysfunction drug Cialis. The warning comes weeks after the US Food and Drug Administration (FDA) banned Cialis from Australia, a country in which Lilly does not produce the drug. Fakes found by FDA and TGA both contain the Viagra active ingredient, sildenafil. TGA Notice
TwoFour Insight has calculated that the Indian Patent Office rejected almost half of biopharma and medical device applications during a two-week period in January. The consultancy analyzed the period to assess whether the office — which made headlines for rejecting Gilead’s Sovaldi patent — is particularly harsh, as its critics in the drug industry claim. TwoFour Insight
The Indian government is to begin selling generic medicines under the Jan Aushadhi brand. Officials have identified 504 essential drugs that the program will source from public and private production plants. The idea is to ensure a supply of cheap, quality medicines, but critics of the scheme doubt the government’s ability to monitor standards. The Economic Times
International regulators have expressed a desire to collaborate more with their peers in India. Speaking at a meeting, most of the 10 global regulators — including the United Kingdom’s Medicines and Healthcare products Regulatory Agency — said they wanted to work more closely with Indian authorities. Information sharing and joint training were both discussed. PharmaBiz
TGA has rejected requests by anesthesiologists to remove over-the-counter cough medicine pholcodine from the market. Some anesthesiologists are concerned about adverse reactions to the drug, but TGA said the evidence is too weak to justify banning products containing the ingredient. ABC
The Indian government is embarking on a program to improve the quality of medical equipment in public health facilities. As much as 63% of existing equipment is thought to be faulty, a figure the government wants to bring down by working with maintenance agencies. The Times of India
TGA has posted a warning about Medtronic’s InterStim and InterStim II neurostimulation devices. A feature on the implantable devices can drain the battery, causing patients to need surgery sooner than expected. TGA Notice
Tags: Asia Regulatory Roundup, Regulatory Roundup
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