EU Regulatory Roundup: Feedback Informs EMA Opinion on Novartis eSource Proposal

RoundupsRoundups | 26 September 2019 | By

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Feedback Informs EMA Opinion on Novartis eSource Proposal
The European Medicines Agency (EMA) has finalized its qualification opinion on Novartis’ eSource direct data capture technology. EMA reached its final position after running a public consultation that attracted responses from organizations including Bayer, Bristol-Myers Squibb and Pfizer.
Novartis triggered the qualification process by asking EMA to assess technology that allows clinical trial site staff to capture study source data electronically at the point of care. That led to the release of a draft EMA qualification opinion in 2018, a four-month public consultation and now to the release of the agency’s final position and the feedback that informed it. EMA published the new documents, which are dated 25 July, this week.
The final opinion hews closely to the draft document EMA released for consultation last year. EMA’s core position on the questions addressed in the opinion is largely unchanged, meaning it still sees no theoretical obstacles to the use of eSource direct data capture in a manner that complies with good clinical practices.
EMA has made some changes, though. The agency has modified a diagram showing how data would move between systems controlled by the investigator and sponsor when information is entered at the point of care. EMA has also added a second acceptable workflow, which was absent from its draft opinion, that describes the pseudonymized entry of special interest data, such as investigator rating scales.
The agency made the changes to the draft in light of feedback from 11 organizations. The changes to the acceptable workflow diagram were among the actions spurred by feedback. The Association of Clinical Research Organizations (ACRO) was among the groups to push back against the original EMA diagram.
“The diagram represents a major simplification of a very complex process and as such is in danger of being misleading,” ACRO wrote. “The figure should be more representative of real-world situations and include an appropriate workflow for handling data corrections.”
Final Opinion, Consultation Responses
EMA Releases EudraVigilance List of Important Medical Event Terms
EMA has released a list of important medical event (IME) terms for users of its EudraVigilance safety database. The list is intended to support classification of suspected adverse reactions and analyses of aggregated safety data.
Working from the official International Conference on Harmonisation (ICH) definition of important medical events, EMA’s EudraVigilance Expert Working Group coordinated the development of criteria to help assess whether an incident qualifies as an IME. The result is a list of terms used in ICH’s MedDRA that meet the IME criteria.
EMA has broken the list up into different therapeutic areas. The cardiovascular section features more IME terms than any other named therapeutic area. EMA is treating relevant forms of embolism, arteriosclerosis in vital organs and other cardiovascular conditions that lead to important organ alterations as IMEs.
The examples of cardiovascular IMEs show how EMA has used qualifiers such as “relevant forms of” to distinguish between events that are described by similar terminology but have different safety implications.
“Certain categories of events that could be considered medically important but are not likely to be relevant in the context of pharmacovigilance activities are excluded from the IME list. These include events due to trauma and exposures and poisonings to external agents,” EMA wrote in the document.
EMA provides further details of its use of qualifiers for specific terms in the IME list. For example, while EMA states, “Terms that describe genetic diseases/syndromes that qualify as an IME are included,” it adds the caveat that “genetic conditions that do not have a drug-related aetiology are excluded.”
EMA Document
Swissmedic Takes Position on Fast-Track Reviews of Tissue-Agnostic Drugs
The Swiss Agency for Therapeutic Products (Swissmedic) has provided advice to developers of drugs that target tumors with certain genetic abnormalities, regardless of the organ affected. Developers of such tissue-agnostic drugs can use Swissmedic’s fast-track pathway if they meet certain criteria.
Knowledge that genetically similar cancers can affect multiple different organs has driven a shift away from targeting tumors based on where they are found in the body. Rather, some companies are developing drugs for approval in all people with a certain genetic marker, regardless of the location of their tumor. This week, EMA made Bayer’s Vitrakvi the first tissue-agnostic drug to win approval in Europe.
Swissmedic has responded to the emergence of tissue-agnostic drugs by updating guidance on its fast-track authorization procedure. The revised guidance features a new annex that discusses the eligibility of tissue-agnostic drugs for the procedure.
In principle, tissue-agnostic drugs can use the pathway. However, the situation is complicated by the need for drugs to target “recognized” or “established” indications. To meet that criterion, an applicant must show the tissue-agnostic indication “can be unequivocally distinguished from other subgroups by virtue of its prognosis, treatment and course, and by the fact that the medicinal product demonstrates general efficacy.” The burden of showing that falls on the applicant.
Swissmedic added the annex to its fast-track authorization guidance on the same day as it updated its temporary authorization document with information about tissue-agnostic products. A different piece of Swiss legislation applies to temporary authorizations, but the outcome is similar. In both situations, the eligibility of a tissue-agnostic product rests on whether an applicant can show that the indication is “recognized” or “established.” 
Swissmedic Guidance
Siding With Patients Over Pharmacists, MHRA Reclassifies Acnecide Products
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has reclassified two acnecide products as being eligible for general sale. MHRA chose to allow people to buy the products without the advice of pharmacists despite opposition to the proposal.
When MHRA sought feedback on the planned reclassification of benzoyl peroxide acnecide face gel and wash earlier this year, it received eight pieces of feedback, half of which came from patients and members of the public. Those four responses were broadly supportive of the proposal, arguing that the need to travel to pharmacies to obtain the product could limit patient access.
However, the other four responses struck a different tone. Those responses, which came from pharmacy groups and a regulatory affairs consultant, argued that patients benefit from the interactions with pharmacists necessitated by the outgoing regulatory classification.
“The directions for usage are complicated and people would benefit from the advice of a trained member of pharmacy staff supervised by a pharmacist on instructions for use, managing the condition and potential side effects,” a representative of the Royal Pharmaceutical Society wrote in feedback to MHRA.
In finalizing its decision, MHRA sided with the patients. MHRA framed the action as part of its efforts to improve access to medicines for self-care when a change can be made without putting patient safety at risk.
Press Release, MHRA Consultation
Other News:
June Raine has taken over as interim chief executive of MHRA. Raine took up the position on 23 September to fill the vacancy created by Ian Hudson’s decision to step down. Sarah Branch will serve as director of MHRA’s Vigilance and Risk Management of Medicines division, the position previously held by Raine, on an interim basis. MHRA Notice
Regulators in Ireland and Switzerland have disclosed recalls of ranitidine medicines. Swissmedic initiated the recall after tests confirmed ranitidine products on sale in Switzerland contained “small quantities” of a carcinogenic contaminant. Irish Notice, Swiss Notice


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