Regulatory Focus™ > News Articles > European Regulatory Roundup: EMA Offers Guidance on Assessing Periodic Safety Update Reports (13 Apr

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Posted 13 April 2017 | By Nick Paul Taylor 

European Regulatory Roundup: EMA Offers Guidance on Assessing Periodic Safety Update Reports (13 April 2017)


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

Defying Commons, Lords Again Press to Enshrine Support for Industry in Pricing Bill

The House of Lords has again voted in favor of an amendment to a drug pricing act that would make the government take account of the need to “promote and support” the life science sector. Members of the second chamber of the United Kingdom parliament backed the proposed caveat despite the House of Commons rejecting a similar amendment recently.

Politicians in the ruling Conservative party argued the original amendment would undermine the government’s ability to impose cost controls and leave it open to legal challenges. Many people in the House of Commons disagreed, but the government, which has a narrow majority, was able to face down the amendment. As such, the bill entered a process known as ping pong, in which it bounces back and forth between the houses until one side backs down, a compromise is reached or the parliamentary year comes to an end.

With the Commons rejecting the amendment and not putting forward an alternative wording that keeps the spirit of the proposal while guarding against unintended consequences, members of the Lords have rewritten the revision. The new proposal features slightly softer language. While the original amendment said the government must have “full regard” to the need to promote the life science sector, the new proposal says it must “take account” of the industry. The amendment was passed by 245 votes to 208, an almost identical result as was achieved by the original proposal.     

The reaction of Lord O'Shaughnessy, the parliamentary under-secretary of state for health, to the new amendment suggests the government is unlikely to accept the new wording when it is put to a vote in the Commons. However, it is possible the persistence of the Lords will lead the minister in charge of the process to engage with the proposal, rather than reject it outright as some think he has done so far.

“He has spent his time trying to get us to take it out of the bill. He has more access to draftspeople than I do. If he had accepted the principle, we could have come up with wording that is more to his taste. Neither he nor his officials have cooperated with that kind of approach,” Lord Warner, the former health minister of the opposition Labour party, said during the debate.

Debate Transcript,

er=1&house=lords">Vote Count

Denmark Tells Patients to Keep Recalled EpiPens Because of Product Shortage

The Danish Medicines Agency (DMA) has told people with recalled lots of EpiPen Jr auto-injectors to keep hold of the products. DMA made the statement after learning pharmacies lacked EpiPen Jr products unaffected by the recall to give in exchange for pens from the potentially faulty batches.

Meda Pharmaceuticals, the distributor of EpiPens in Denmark and other European countries, told regulators including DMA last week of the need to expand its recall to include two lots of the pediatric pens. At that time, DMA said patients with auto-injectors affected by the recall should take the products to the pharmacy as soon as possible because they may be faulty. The concern stems from two reports of EpiPens not working properly.

DMA changed its advice two days later. The current recommendation is for parents of children at risk of an anaphylactic reaction to keep hold of their EpiPen Jr devices and use them if needed. If the device does not work as expected, DMA wants people to immediately call emergency services. Users of auto-injectors can tell whether a device has triggered successfully by checking whether the orange tip of the EpiPen has grown in length.

These potentially faulty devices must stay on the market for now because Meda lacks enough pens to replace all products in the affected batches. DMA expects Meda to deliver new pens on 20 April. The emergence of the supply shortage follows the expansion of the recall. Since starting to recall batches from nations including Australia, Denmark, Finland, Ireland, Japan, New Zealand, Norway and Sweden, distributors have added new lots to the process and a new country: the US.

In Denmark, this has created a shortage of EpiPen Jr auto-injectors from batches unaffected by the recall. Other regulators, such as the Medical Products Agency (MPA) of Sweden, alerted patients to the expanded recall but have not followed DMA in warning them about a shortage of EpiPen Jr pens.  

DMA Notice (Danish), MPA Alert (Swedish)

EMA Posts Guidance on Assessment of Periodic Safety Update Reports

The European Medicines Agency (EMA) has provided guidance on periodic safety update reports (PSURs). EMA’s explanatory note and Q&A document build on its two years of experience with the single assessment of PSURs by addressing issues raised by companies and seeking to improve the assessment process.

Europe moved over to single assessments of PSURs about nationally authorized medicines in 2015. Prior to that, marketing authorization holders of medicines containing the same active ingredient each submitted reports to the national competent authorities overseeing their products. EMA put its Pharmacovigilance Risk Assessment Committee (PRAC) in charge of assessing PSURs with the support of a representative of a member state in 2015 to streamline and harmonize the process.

Now, two years later, EMA is trying to further improve the process through two documents. One of the texts, an explanatory note to module VII of the good pharmacovigilance practices, is intended to address issues brought up by companies since the start of single assessments. The text covers the scope of information to include in PSURs, the provision of study reports and signal evaluation. EMA foresees the note ultimately forming the basis of an update to module VII.

The other document is a Q&A on single assessments of PSURs designed to guide assessors through the process. EMA hopes the text will raise the standard and consistency of PSUR assessments. To achieve these goals, EMA has created a document that covers the fundamentals of the process, from the purpose of PSURs to the link between single assessments and other regulatory procedures.  

Press Release, Explanatory Note, PSUSA Q&A

ENVI Backs Move to Protect Medical Devices from Hazardous Substance Restrictions

The Committee on the Environment, Public Health and Food Safety (ENVI) has backed plans to protect medical devices from restrictions on the use of hazardous substances. Unless action is taken, it will be illegal to resell certain medical devices from mid-2019 onward. 

ENVI’s comments follow the European Commission’s publication of a proposed directive addressing the topic. That proposal is seeking to delay the implementation of restrictions on medical devices to avoid a situation in which the resale of existing products is prohibited. While wanting to phase out the use of certain substances, officials think ending a secondary market in devices is inconsistent with the harmonization of product legislation.

Politicians at ENVI agree. The committee has proposed some changes to the commission’s document but has retained its intent. In its report, ENVI said restricting the sale of medical devices would be “against the principles of a circular economy, particularly as it would reduce the lifetime of many products.”

ENVI Report, Proposed Amendment

Other News:

The UK Medicines and Healthcare Products Regulatory Agency has dropped ”gsi” from its email addresses. Use of the abbreviation for “government secure internet” dates back to 1996 but is no longer seen as necessary. MHRA Notice


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