European Regulatory Roundup: EMA Proposes Major Changes to Risk Management (3 March 2016)

Posted 03 March 2016 By Nick Paul Taylor

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Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

EMA Proposes Major Changes to Pharmacovigilance Risk Management System Guidelines

The European Medicines Agency (EMA) has proposed major changes to its good pharmacovigilance practices (GVP) module on risk management systems. EMA wants to implement the modifications to bring the guidelines in line with its current thinking, which has evolved over the past three years as it has gained experience with the key areas of focus in risk management plans (RMPs).

GVP module V, which covers RMPs, was first released in 2012, the same year that EMA created the Pharmacovigilance Risk Assessment Committee (PRAC). The committee, which reviews RMPs as part of its responsibilities, has accrued knowledge of how best to approach plans over the past few years. Revision 2 of the GVP module is the first version of the document to benefit fully from the knowledge. By incorporating the experience into its guidelines, EMA thinks it can better advise companies about the creation of RMPs, which must be approved by regulators in advance of a drug being authorized.

In opening the revised text to the industry for consultation, EMA has selected four topics about which it is particularly keen to receive feedback. Some of the issues highlighted by EMA for discussion relate to its attempt to refocus RMPs to ensure all actual and potential safety concerns regarding a product are covered adequately by the plan. EMA, which devotes three pages of the text to these “identified and potential risks,” is asking if people want RMPs to provide a focused list of safety concerns or a comprehensive catalog that aligns with periodic safety update reports (PSURs).

As it stands, EMA thinks the proposed risk definitions and guidance could, in the post-authorization stage, result in RMPs being associated with a list of safety concerns that is a subset of those defined in the PSUR. Whether this is desirable is at the heart of one of EMA’s four questions for the industry. The other questions cover whether studies conducted voluntarily, as opposed to at the behest of the competent authority, and extra risk minimization materials should be included in the annexes of the RMP. EMA is also seeking advice on whether to cut a whole section in light of its new terminology. 

The module V consultation is taking place in parallel to a review of proposed changes to a template for RMPs. EMA has revised the template to bring it into line with its planned changes to module V, notably its attempts to create a more focused risk management system. By making the changes to the template, EMA thinks it can simplify the way companies present risk management information to regulators. The comment periods on both documents are due to close on 31 May, positioning EMA to aim to have a finalized version of module V come into effect in the third quarter of 2016.

EMA Statement, Draft Guidelines, Draft Template

NICE to Take Control of Revamped Cancer Drugs Fund

The National Institute for Health and Care Excellence (NICE) is set to take control of England’s Cancer Drugs Fund (CDF). When the new CDF structure comes into place in July, NICE will gain the power to block cancer drugs from joining the funding scheme, cutting off a back door to reimbursement that has been in place since 2011.

Currently, when NICE rejects a cancer drug on the grounds that it is perceived to offer poor value to the healthcare system, companies can apply to have the product reimbursed by the CDF. However, with the CDF repeatedly going over its budget, which started out at £200 million ($281 million) but has now swelled to £340 million, and critics questioning the value of these outlays, officials have sought to find a model that fixes some of the fund’s failings without cutting off a route through which cancer patients can access treatments.

After a 12-week consultation, the government has now presented its compromise. When a drug is submitted to NICE for assessment, the cost watchdog will respond with one of three answers within 90 days of marketing authorization. Drugs that receive a ‘yes’ from NICE will be reimbursed under the budget of the National Health Service. If a cancer drug is classed as a ‘maybe’ by NICE, it will be reimbursed under the CDF for a limited time. NICE will gather real-world efficacy data on “maybe” drugs for two years. Drugs that receive a “no” from NICE will be shut out from the healthcare system.

NICE is gaining oversight of the CDF as part of a raft of reforms of the fund. The latest iteration of the CDF will operate as a “managed access” fund with a fixed budget of £340 million, a model that NICE and other advocates claim will give promising drugs that lack data compelling enough to justify their routine use a chance to prove themselves in real-world settings. “[The CDF] will provide faster access for patients, I think that's really important, and I think it will bring clarity to which drugs are the most effective sooner than we know at the moment,” a spokesperson for NHS England told BBC News.

The industry is less enamored with the new structure. Paul Catchpole, value and access director at the Association of the British Pharmaceutical Industry, said: “If cancer medicines go through more or less exactly the same NICE appraisal process that was in place five years ago — which necessitated the setting up of the CDF in the first place — we will largely get the same answers as before — the majority of medicines will be turned down.” 

NHS England Report, BBC News

Swissmedic Adds Requirements for Authorization of Products Based on Genetic Resources

The Swiss Agency for Therapeutic Products (Swissmedic) has revised its drug authorization process in response to the passing of legislation about the use of genetic resources or traditional knowledge.

Active substances and excipients developed using genetic resources or related traditional knowledge accessed after 12 October 2014 are affected by the new requirements. Applications for products that fall into this category must include a registration number from the Swiss Federal Office for the Environment. Swissmedic has amended its application forms to reflect this requirement.

The change follows the passing of the Nagoya Ordinance, legislation that stems from Switzerland’s involvement with the Convention on Biological Diversity’s (CBD) Nagoya Protocol. CBD negotiated the protocol to support the fair and equitable sharing of benefits deriving from the use of biological diversity.

Swissmedic Notice

MHRA Revises Change of Ownership Application Process to Prevent Delays

The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has revised the process for applying to change the ownership of medicines marketing authorizations.

MHRA has made the changes in an attempt to prevent delays that could cause it to miss its 42-day deadline for handling change of ownership applications (COAs). COA forms now feature advice on how to complete the document, plus details of the required supporting documentation.

The regulator is aiming to respond to filings within 30 days, with applications that are free from issues that require the submission of further information receiving clearance within this time frame. MHRA wants applicants to respond to its requests for further information within 14 days.

Applicants that fail to respond within 14 days will have their submissions withdrawn and be charged the full fee.

MHRA Alert

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, Government affairs, Manufacturing, Postmarket surveillance, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC, MHRA, NICE

Tags: good pharmacovigilance practices, NICE, Cancer Drugs Fund, Swissmedic

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