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Posted 11 April 2017 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Therapeutic Goods Administration (TGA) of Australia has told manufacturers to review their quality systems and the effectiveness of their data management and integrity controls. TGA made the request in a post detailing its intent to step up its focus on data management and integrity.
Officials at TGA published the post to clarify the regulator’s formal position on data management and integrity practices and felt such clarification was needed considering the frequency with which good manufacturing practice (GMP) inspections have uncovered data integrity failings over the past five years. Inspectors from the US and EU have uncovered problems at tens of companies in India, China and elsewhere, leading to increased interest in the subject.
Whereas the US Food and Drug Administration responded to the situation with draft guidance, TGA has opted to remind manufacturers of the obligations placed on them by its GMPs and those created by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). The text provides a brief introduction to data integrity, the ALCOA+ principles and what TGA wants manufacturers to do to ensure their operations are compliant.
TGA has asked manufacturers to review their existing quality system procedures with a view to showing they ensure the integrity of data. Specifically, TGA wants companies to assess the systems they use to generate, issue and control physical documents and batch records. The agency is also asking manufacturers to review their processes for electronic data, including routine assessments of source data and audit trails. Other requests include the validation of electronic systems against Annex 11 and the review of systems for storing and archiving GMP data.
Officials want manufacturers to perform these reviews in conjunction with assessments of the effectiveness of data management and integrity controls built into the self-inspection program of their quality systems. TGA also expects manufacturers to review the effectiveness of the controls in place at key service providers, such as contract manufacturing and testing partners.
If manufacturers uncover data integrity control weaknesses during any part of the review, TGA wants them to develop and document actions to fix the problem. Suggested responses include the updating of quality management systems, equipment and software.
The Drug Controller General of India (DCGI) Dr. GN Singh has ordered companies to upload details of their production facilities to the Sugam online portal. Singh made the request to further India’s attempt to create a database of drug manufacturing plants.
In a notice to pharmaceutical manufacturers and state regulators, Singh asked all drugmakers that are yet to register on Sugam to sign up to the online portal. A state drug controller will then review the information and authenticate the account, after which the company can upload details of its manufacturing facilities. Companies already registered on Sugam can skip straight to the uploading of information about their production plants.
DCGI officials want companies to provide details of all their Indian plants and are allowing them to upload information about sites in multiple states from a single account. If Singh can get companies to comply with the request, the Central Drugs Standard Control Organization (CDSCO) will gain a comprehensive and centralized online repository of information about the facilities it regulates.
The experience of other agencies suggests it may take time to collate such a database. When the National Pharmaceutical Pricing Authority asked manufacturers to register on its database, it initially saw little response. That only changed when it made compliance a prerequisite for using certain pricing processes. The drug manufacturing facility notice does not mention any deadlines or punishments for failing to comply.
Singh made the request in a notice that also covered the development of a database of approved drug formulations. As with the manufacturing plant request, Singh wants companies to upload data for authentication by the relevant state drug controller.
The Drug Regulatory Authority of Pakistan (DRAP) is seeking a consultant to help it fix the prices of cardiac stents and certain other medical devices. DRAP wants the consultant to calculate the cost of making devices and getting them to patients with a view to using the data to inform price caps.
Officials primarily want the consultant to study the costs of cardiac stents, defibrillators, pacemakers, prosthetic heart valves and cardiac balloon catheters. This will entail looking at the landed cost of imported devices, breaking down typical expenditure on sales, marketing and other operating expenses and determining the percentage by which the price is marked up as devices move along the supply chain.
DRAP also expects the consultant to suggest a “reasonable” profit margin for importers. In this regard and others, DRAP wants the consultant to look to international practices for fixing the price of medical devices.
The most notable recent example of a price cap on cardiac stents is in India, Pakistan’s neighbor. India set the price of drug-eluting and bare metal stents at Rs 30,000 ($465) and Rs 7,500, respectively. Those prices are significantly lower than some charged by hospitals in India prior to the introduction of the price cap, but the country’s cost watchdog claims they are high enough to enable companies to turn a profit.
India’s action spurred interest in capping stent prices in several Asian countries. Yet, while DRAP is keen to learn from the experience of countries such as India, it is not wedded to following the same approach. The agency is tasking the consultant with coming up with ways to improve the cost-plus pricing mechanism, and is also open to suggestions for alternative approaches based on empirical evidence.
DRAP is accepting expressions of interest in the consultancy role until midday local time on 24 April.
China Food and Drug Administration (CFDA) is planning to increase its drug budget by 31% this year. The increase follows a 24% rise last year and means overall spending will grow again in 2017 despite CFDA cutting back in some areas, notably medical devices.
CFDA plans to spend 7.3% more in total this year than last. This figure masks variations in spending at different departments. The drug operation, the largest single item in the CFDA budget, is due to spend 31% more than in 2016, continuing a period of double-digit budget increases for the unit. China has increased spending to enable CFDA to cope with multiple tasks facing the unit, such as the need to manage the backlog of applications and raise the quality of generic medicines.
Other units will have to manage with reduced budgets. Last year, CFDA increased spending on its medical device operation by 126%, but it is reining in outlay for 2017. The 20% cut planned for this year will still leave the unit with significantly more money than it had in 2015, though. CFDA’s big investment in the unit last year covered a period in which it overhauled many aspects of medical device regulation.
CFDA Budget (Chinese)
Tags: data integrity, DCGI, pharma manufacturing, DRAP, stents
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