European Regulatory Roundup: EU Puts Clinical Trial Regulation at the Top of IT Roadmap (13 August 2015)

Regulatory NewsRegulatory News | 13 August 2015 |  By 

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

EU Puts Clinical Trial Regulation at the Top of IT Roadmap

The European Medicines Agency (EMA) has adopted a roadmap for its IT services. Having committed to the plan, EMA will spend the next two years working to implement IT aspects of the Clinical Trial Regulation, notably a reporting portal, supporting database and upgraded safety event module.

EMA signed off on the strategy earlier this month, meaning both it and its peers at the Heads of Medicines Agencies (HMA) have now endorsed the European Union strategy document. The seven programs described in the document cover many of the hot topics at EMA, reflecting the vital role IT is playing in regulation today. As well as detailing plans for clinical trials, the roadmap plots the strategy for pharmacovigilance, marketing-authorization applications and data integration.

The roadmap shies away from stating exactly how the programs should be achieved, but its authors are clear about the end goals. In the case of clinical trials, the planned IT systems should provide “a platform to facilitate multistate assessment of clinical trials, fostering effective collaboration and communication between [National Competent Authorities] and with sponsors,” the authors wrote. Such a system will also improve data quality, transparency and simplify the submission process.

Biopharma firms are set to realize some of the expected benefits, but could also be affected negatively in the short term. The trial portal and database will necessitate the reorganization and centralization of application and surveillance processes, while the EU has warned mandatory use of Electronic Application Forms (eAFs) may create extra work and lengthen filing creation timelines in the interim.

By outlining what changes are coming and how they may affect the industry, the EU is trying to give companies time to adjust their operations. For example, the roadmap encourages companies to start planning changes to their IT systems and product database models ahead of the adoption of the International Organisation for Standardisation (ISO) approach to Identification of Medicinal Products (IDMP). The approach is intended to support data integration.

EMA Statement, EU Roadmap

Britain Scolds Pfizer for ‘Excessive and Unfair’ Drug Prices

The British Competition and Markets Authority (CMA) has accused Pfizer and Flynn Pharma of ratcheting up the cost of an epilepsy drug by 2,600%. CMA will now assess the companies’ defenses of their pricing practices before ruling whether they have breached British and EU competition laws.

Pfizer and Flynn Pharma are being targeted over the pricing of phenytoin sodium capsules, a therapy for epilepsy. The drug was sold by Pfizer as Epanutin until 2012, at which time it passed on the rights to the product to Flynn Pharma. Pfizer continued to produce the drug and supply it to Flynn Pharma for distribution. It is under this new model that CMA has identified a possible breach of the law, the blame for which it has placed on both companies, Reuters reports.

CMA said Pfizer charged Flynn Pharma up to 17 times the historic price of the drug. Flynn Pharma then sold the product for as much as 27 times what Pfizer used to charge. The new price has hit the National Health Service (NHS) hard. Historically, the NHS spent around £2.3 million ($3.6 million) a year on phenytoin sodium capsules. In 2013, the organization’s outlay on the drugs shot up past £50 million. With the NHS struggling to manage its budget, such price rises are problematic.

“While businesses are generally free to set prices as they see fit, those that hold a dominant position have a special responsibility to ensure that their conduct does not impair genuine competition and that their prices are not excessive and unfair,” Ann Pope, the CMA's senior director of antitrust enforcement, said. Pfizer has defended its pricing, though. The company said phenytoin sodium capsules used to be sold at a loss, so price increases were needed for it to continue producing the drug.


MHRA to Start Standalone Inspections of Pharmacovigilance Service Providers

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) is to start performing standalone inspections of pharmacovigilance service providers. MHRA thinks moving to fee-bearing inspections of service providers will cut the number of times each business is assessed.

As it stands, MHRA inspects service providers during assessments of marketing authorization holders (MAHs). Consequently, a service provider that works for five MAHs may be inspected five times by MHRA. The regulator has identified this approach as inefficient and has proposed fee-bearing inspections for service providers as an alternative. MHRA thinks the new model will cut the number of times a service provider is inspected and the frequency with which MAHs need to audit suppliers.

If the proposal comes into force, MHRA could assess the pharmacovigilance activities of multiple MAHs in one inspection of a service provider. Equally, service providers could then implement fixes to problems identified by MHRA inspectors across all of their clients. MHRA started moving toward the adoption of such a model late last year, when it asked 22 service providers to complete a survey and to volunteer for an inspection pilot project.

MHRA received completed surveys from 10 companies, seven of which volunteered for the pilot project. The regulator has picked two of the volunteers for the next step of the pilot project, which will see its inspectors visit the companies later this year.

Press Release

ABPI Backs NICE’s Approach to Biosimilar Versions of Remicade

The Association of the British Pharmaceutical Industry (ABPI) has spoken out in support of how the National Institute of Health and Care Excellence (NICE) is handling the arrival of biosimilar versions of Remicade. ABPI praised NICE for publishing a “helpful implementation resource” for NHS staff.

Hospira and Celltrion won EMA approval for versions of Johnson & Johnson’s Remicade in 2013 and brought their products to market in the UK earlier this year. To help NHS staff with the introduction of the products, NICE released an advice document late last month, in which it recommends teams identify clinical and pharmacy champions to drive the adoption of biosimilars. At the same time, NICE reiterated that clinical judgement — not value — should take priority when making decisions.

ABPI has welcomed the approach taken by NICE. “ABPI is pleased that NICE has published this helpful implementation resource, which will support NHS organisations put in place the necessary steps to consider the introduction of greater numbers of biosimilar medicines as they reach the market,” Paul Catchpole, ABPI's director of value and access, said.

ABPI Statement

Other News:

The British Pharmacopoeia (BP)has merged its websites. Under the new system, all subscriptions and BP chemical reference standard orders will go through “This is a significant enhancement of our online publication which will provide our users with a superior experience,” Samantha Atkinson of British Pharmacopoeia and Laboratory Services said. Statement

EMA has revised its guidance on post-authorization safety studies (PASS). The draft addition to its Module VIII pharmacovigilance guidelines lists reasons why a company may need to run PASS. EMA also adopted minor changes to Module IV. GVP Guidelines, Module VIII Guidelines, Module IV Guidelines, Regulatory Focus

MHRA has added an extra good clinical practice (GCP) symposium to its calendar to meet demand from industry. The regulator has also started accepting bookings for its upcoming good laboratory practice (GLP) symposium. GCP Symposium, GLP Symposium


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