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Posted 19 April 2016 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The China Food and Drug Administration (CFDA) has outlined plans to overhaul regulation of the supply chain in the wake of a vaccine scandal currently engulfing the country. Officials are looking to implement a full vaccine traceability system, strengthen oversight of the cold chain and reform the centralized procurement mechanism in an attempt to ensure the quality of products in the country.
CFDA has been spurred into action by the sale of improperly stored vaccines. The regulator accused nine companies of selling improperly stored or out-of-date vaccines last month, leading to the detention of 202 people and filing of 192 criminal cases, The Associated Press reports. Investigations into the issue have reportedly uncovered failings within the government. In response, China has fired or demoted more than 350 local officials, the poor performance of whom is thought to have enabled the substandard vaccine operations to continue.
The government is looking to back up these near-term initiatives with regulatory changes designed to ensure storage and distribution failings are identified and resolved quickly in the future. Specifically, officials have put forward an eight-step proposal. The first step is to prohibit vaccination units from buying products directly from manufacturers. Instead, China will operate a centralized procurement model, in which all vaccine sales are channeled through regional centers. The shift is intended to put a stop to the complex, many-to-many supply chain that enabled substandard operators to prosper.
CFDA also wants to gain greater oversight over the revised supply chain network its first proposal is intended to create. The regulator is proposing a full, production-to-usage traceability system to give it oversight and an audit trail for vaccines at each step in the supply chain. Full details of how CFDA intends to achieve this goal are yet to emerge. In parallel, CFDA is planning to step up its monitoring of the cold chain through temperature recording and other measures. Again, the regulator is yet to flesh out how this will work in practice.
Alongside attempts to ensure vaccines are handled properly during the steps between the producer and patient, CFDA is working on initiatives aimed at the end of the supply chain. A compensation insurance mechanism targeted at people who suffer abnormal reactions to vaccines is in the works. The measure could provide reassurance to a populace that has reportedly become wary of the safety of vaccines in the country.
CFDA Notice, Technical Guidance, More (All Chinese), The Associated Press
Pakistan is planning to revise its drug legislation to make the misuse of powers by regulatory officials an offence punishable by imprisonment. The proposal, which is currently being considered by the National Assembly standing committee, is part of a clutch of measures intended to punish manufacturers of spurious or unlicensed medicines and the officials who enable them to flout the law.
If the amended law comes into force, any inspector found to be “misusing” the powers conveyed to them through the Drug Regulatory Authority of Pakistan (Drap) Act 2012, or “acting in contrivance to the provisions” of the bill, will face up to one year in prison and a fine of up to PKR 100,000 ($950). As it stands, the legislation, which is the founding text of the Pakistani drug regulatory body, lacks any details regarding the punishment for staff who aid illegal activities. The regulator has been dogged by allegations of corruption, including the claim a “mafia” within DRAP holds sway over decisions.
Last year’s appointment of a CEO with a background in industry was designed to lessen the influence of this group, as are plans to hire up to 200 additional staff. Pakistan’s Federal Investigation Agency (FIA) has also stepped up its oversight of suspicious activities at the regulator, resulting in the questioning of four DRAP officials and the start of a probe of the minutes of meetings late last year. The amendments now being discussed in parliament would establish clear punishments for anyone found by FIA to be misusing their powers.
The organizations enabled by corrupt officials are also in line to receive tougher punishments. Under the revised legislation, the unlicensed production and importing of drugs, as well as the handling of spurious or unregistered products, will carry penalties of 10 years or more in jail and a fine of up to PKR 1 million ($9,500). Currently, the punishment is set at three to 10 years in jail. Similar changes are planned to the legislation covering importers and manufacturers of counterfeit medicines, who will face longer jail terms and hefty fines if the revised legislation comes into force.
Legislative Proposal, DRAP 2012, Dawn
China is planning to increase CFDA’s medical device budget by 126% in 2016. The rapid escalation of spending amounts to the biggest increase in percentage terms for any function at CFDA, which, as a whole, is set to see its budget rise by 6.5% in 2016.
In 2015, medical device affairs was a relatively insignificant item in CFDA’s budget, accounting for just 3% of overall spending. This is set to change in 2016. With CFDA growing its medical device affairs budget by 126%, the function will come to account for 7% of every renminbi spent by the regulator. The sharp increase follows a period in which CFDA has overhauled multiple aspects of its regulation of the medical device sector.
Drug affairs is also set to receive a notable boost to its budget. The drug affairs unit, which at 28% of all CFDA spending in 2015 is a far larger division than the medical device operation, will receive 24% more this year than last. Some of the extra money available to the drug and device divisions is being reallocated from the “other” category, a sizable item in the CFDA budget for 2015 that is being cut by 34% this year.
These ups and downs work out as a 6.5% increase in the overall budget, an uptick which is well above the rate of inflation in China. The increase comes at a time when the regulator is working on multiple fronts to raise standards and strengthen its oversight.
CFDA Budget (Chinese)
CFDA has released checklists to help its employees monitor the quality of 25 types of medical devices. Each checklist details the factors regulatory officials should be aware of when dealing with a specific device, such as the need for manufacturers of sterile syringes to employ full-time quality inspectors.
The checklists are broken down into different categories. For example, the need for sterile syringe facilities to employ an appropriate number of trained quality control inspectors is categorized as an organization and personnel issue. Other categories include plant and facilities, equipment and production management.
CFDA has provided details of what inspectors should be looking for in each of these categories when inspecting operations involved in the production of tens of common pieces of medical equipment. Other devices covered by the checklists include disposable intravenous catheters, blood collection systems and bone implants.
The creation of the checklists follows a period of several years in which CFDA has revised the good manufacturing practices for medical devices and documents covering its supervision of the sector.
CFDA Notice (Chinese)
Tags: Asia Regulatory Roundup, China vaccines, Pakistan drug regulations, China medical devices
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