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Regulatory News | 21 March 2017 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Indian government is proposing to create an electronic platform to monitor the drug supply chain. Officials want all manufacturers, distributors and pharmacies to register on the platform and upload details of batches they supply and receive in an attempt to raise drug standards in India.
India’s Ministry of Health and Family Welfare has created the plan in response to ongoing concerns about the quality of drugs sold in the country, the use of the internet to sell medicines and the rise of antimicrobial resistance. Officials previously tried to address some of these concerns through the addition of barcodes to primary, secondary and tertiary packaging. However, while the model is used for exports, officials encountered local resistance to planned track-and-trace requirements, leading them to consider other ways to improve oversight of the domestic supply chain.
A public consultation on the development of “a robust e-enabled structure for regulating sale of medicines” is the result of these considerations. Government officials envisage all players in the finished product supply chain, from manufacturers to pharmacies, registering on the platform. No pharmacy, be it a bricks-and-mortar store or an online firm, will be allowed to sell drugs unless they register on the platform.
Whenever a manufacturer sells drugs to a distributor, it will upload details of the transaction to the online portal. Officials foresee companies providing details such as the batch number, expiry date and quantity supplied. Then, when the distributor sells the products to a pharmacy or other firm in the supply chain, it will also enter details of the transaction. Finally, pharmacies will provide details of all the products they receive, sell or return to the manufacturer.
By making companies report each step in the supply chain, officials think they can track how drugs move through the system without making manufacturers add barcodes to their packaging. The approach differs from how the United States and European Union are trying to secure their supply chains through the Drug Supply Chain Security Act and Falsified Medicines Directive, respectively, but there is overlap between the goals of the proposals.
To get the project going, the Ministry of Health and Family Welfare plans to provide a grant to an as-yet-unidentified autonomous body that will develop and maintain the portal. The autonomous body will receive financial support from the Consolidated Fund of India for the first two years, after which it is expected to generate enough cash to run the portal without government help. Officials think the portal could generate revenue by charging companies a registration fee or taking a 1% cut of the cost of drug transactions.
The Ministry of Health and Family Welfare is accepting feedback on the proposal until April 15.
Australia has begun a consultation on its planned adoption of a provisional approval pathway. The proposal positions the Therapeutic Goods Administration (TGA) to formalize the process of seeking regulatory approval in Australia based on early clinical data.
TGA wants to put the pathway in place to enable drug developers to gain time-limited provisional registrations for certain candidates that are yet to generate enough clinical data to support a full approval. The idea is to ensure drugs can reach a wide audience once the risk posed by the lack of data is outweighed by the harm likely to be caused by withholding the product any longer. TGA has previously registered such drugs in exceptional cases, but the proposed pathway will mark the first time this process is formalized and transparent.
The risk-benefit balance sought by TGA means the scheme will only be open to medicines early data suggest could deliver “significant benefit to patients with inadequate treatment options for serious and life-threatening conditions.”
Under the proposed process, sponsors will seek a pre-designation meeting with TGA six to seven months before submitting a dossier. TGA then expects sponsors to file a designation application for the provisional approval pathway. Medicines deemed to meet the eligibility criteria will be classed as suitable for provisional approval applications for six months. TGA will extend the period by a further six months in some circumstances.
In that window, sponsors must file a provisional approval registration application and supporting dossier. If TGA approves the application, it will grant the product a two-year registration that can be extended by the regulator. The expectation is companies will use the two years to generate the data they need to transition to a full registration.
TGA plans to add caveats to the two-year provisional approval window. The regulator expects the sponsors of such products to meet certain requirements, including some relating to postmarket safety reporting. TGA has initiated a separate consultation about changes to safety reporting.
Publication of the consultation texts follows the 2015 Review of Medicines and Medical Devices Regulation and subsequent government acceptance of its proposal to follow other regulators by creating a provisional approval pathway and strengthening postmarketing monitoring.
The Drug Controller General of India (DCGI) has created a pathway to legitimacy for manufacturers of certain fixed-dose combinations (FDC). DCGI Dr. GN Singh set up the process to help companies with FDCs that are deemed rational but lack the no-objection certificates needed to be sold.
The creation of the situation dates to January 2013. Back then, manufacturers of FDCs permitted for sale by state bodies without DCGI approval were given 18 months to prove the safety and efficacy of their products. A committee assessed the submissions. Combinations that were declared rational by Professor CK Kokate and his collaborators received certificates allowing their continued manufacture and sale.
However, the process failed to provide regulatory clarity for all FDCs. Some companies want to make FDCs deemed rational by the committee but lack a certificate clearing them to do so. A letter sent by Singh this week is intended to create a pathway for such companies.
Prospective manufacturers of rational FDCs must send Form 44 and the accompanying fee to the central licensing body. The submission must state whether a state body has already permitted the sale of the FDC. Manufacturers can expect to receive a certificate clearing the FDC for manufacture and sale within 30 days. If a certificate is not issued within 30 days, the filing will be deemed approved.
Singh has told state regulators to allow the manufacture of such FDCs, providing the operation meets other requirements. Manufacturers of the affected FDCs must submit periodic safety update reports.
TGA is seeking feedback on planned changes to pharmacovigilance inspections and adverse event reporting. The proposal seeks to add a black triangle scheme to alert patients and physicians when a drug is new to the market and as such lacks extensive real-world adverse event data.
Officials hope the black triangle logo will encourage people to report adverse events. The idea is based on a similar scheme in the European Union, a part of the world TGA looks to for inspiration in other parts of the document.
TGA plans to follow the EU in implementing a pharmacovigilance inspection program. Like the EU, TGA is proposing to take a risk-based approach to prioritizing which sponsors to inspect. New medicines and those registered through the provisional approval pathway could face particular scrutiny.
Tags: Asia regulatory roundup, India drug supply, TGA pharmacovigilance