Euro Roundup: EMA issues directive on conducting registry-based studies


The European Medicines Agency (EMA) has published recommendations on the main methodological aspects specific to the conduct of registry-based studies by marketing authorization holders and applicants.

The EMA, as part of its Patient Registries Initiative and Inter-Committee Registries Working Group, explored ways to improve the use of patient registries to support regulatory decision-making. The project resulted in a series of workshops which generated recommendations and later a discussion paper. Today, the EMA has brought together information and recommendations from other groups in the European Union and overseas into a directive on registry-based studies.

The guideline distinguishes between registries and registry-based studies, explaining that in the latter a specific research question is examined “using the data collection infrastructure or the patient population of one or more registries. of patients ”. The length of follow-up, patient recruitment and data collection are all dictated by the research question.

Elsewhere in the directive, the EMA explains how marketing authorization holders and applicants can use the results of registry-based studies. The acceptability of the evidence from the studies depends on the product, the registry and the study, leading the EMA to advise drug developers to consult it promptly or to consult a competent national authority.

The EMA identifies a range of potential uses for the results of registry-based studies. Pre-authorization, the agency expects preclinical studies and clinical trials to form the core of the evidence for a drug. Yet registry-based studies can play a role, for example by providing evidence of how a disease is treated in the real world or by contextualizing the results of uncontrolled clinical trials. When using evidence pre-approval, the EMA recommends discussing the acceptability of the proposed approach with regulators, health technology assessment bodies and payers.

A different set of use cases apply once a product is on the market. “Patient registers can serve as the basis for recruitment and randomization for RCTs and non-interventional studies, post-authorization efficacy studies and post-authorization safety studies performed after marketing authorization. . They can allow patient records to be linked with other data sources such as biobank data, census data or demographic data, ”says the directive.

The following section of the 35-page guideline describes how to plan a registry-based study, design the protocol, select the patient population, and collect, analyze and report the data. These topics occupy approximately the first half of the document. The remainder of the guideline is devoted to legal issues, patient registry considerations and appendices such as a checklist for assessing the suitability of registries for registry-based studies.

EMA guideline

European Parliament votes for more transparent COVID-19 vaccination policies

The European Parliament has called for legislation to make the search, purchase and distribution of COVID-19 vaccines more transparent to help counter hesitation and misinformation about vaccines.

Many requests relate to current and future contracts between the Commission and manufacturers of COVID-19 vaccines. The resolution, which was adopted by 458 votes to 149, with 86 abstentions, calls on the Commission to publish without delay the unredacted versions of the purchasing contracts. Parliamentarians want the disclosures to cover the amount of public investment that has been spent on vaccine development, the prices and the number of doses sent to each country.

Other requests relate to clinical trial data. Politicians want the Commission to “ensure that contracted companies make available full clinical trial results and potential research protocols on a COVID-19 vaccine for evaluation, as soon as possible, by independent scientific experts,” beyond EMA experts ”. The request is for statistical analysis plans, clinical studies and reports.

Dolors Montserrat, chair of the petitions committee, made the demands as part of a campaign to tackle vaccine hesitancy. “The petitions show that some citizens are reluctant to get vaccinated. This is why we need to be transparent about how COVID-19 vaccines are developed, procured and distributed. For the strategy to be successful, the public needs to receive more information, ”Montserrat said.

Press release, Resolution adopted

EMA answers questions about sending data to the EudraVigilance dictionary

The EMA answered dozens of frequently asked questions about electronic submission of investigational drug data to the EudraVigilance Extended Drug Dictionary (XEVMPD).

The document covers fundamental issues, such as the legal obligation to submit data, to more specific queries. More specific questions include: “In our clinical trial we are using a drug that is already authorized. However, it is being studied for a new indication not listed in the SPC. How should we submit such a product to XEVMPD? “

The EMA divided the beginning of the document into questions about submitting investigational drugs, drugs in development, and sponsor information. The rest of the text covers topics such as pharmaceutical information, printed product information, and chemical therapeutic anatomical code.

One question is whether promoters should submit placebos information to XEVMPD. The EMA said only information on the active ingredients of the investigational drug should be submitted, citing other documents to make its case.


MHRA calls on sponsors to use combined review route ahead of January change

The UK Medicines and Health Products Regulatory Agency (MHRA) has asked sponsors to start using its combined review channel for clinical trial applications. The combined review will become the way all filings will be processed from January, but the MHRA wants sponsors to use the lane before that date.

In an update to its guidelines on authorizing clinical trials, the MHRA said its combined review service, formerly known as Combined Ways of Working, will become the way all new trial applications Investigational Drug Clinics (CTIMP) are prepared, submitted and reviewed starting January 1. The combined review allows promoters to make a single filing and receive a single UK decision.

While the mandatory use of the track is still two months away, the MHRA is asking sponsors who “have new CTIMP applications planned in the weeks or months to come” to apply for a combined review.

Combined review requests “should be initiated and submitted using the new part of the Integrated Search Application System (IRAS) and not the standard part of IRAS,” the MHRA said. The regulatory requirements and fees are the same as for the old uncombined exam. However, the MHRA advises applicants to refer to the Health Research Authority’s website, rather than its guidelines, for information on the stages of submitting, processing, and reviewing the application.

MHRA Guidelines

Commission carries out unannounced antitrust inspections at animal health company

The European Commission carries out unannounced inspections of “a pharmaceutical company active in the field of animal health in Belgium”.

Officials launched the inspections over “concerns that the inspected company may have violated EU antitrust rules which prohibit abuse of dominance.” The Commission is working with the Belgian competition authority on inspections, which constitute a preliminary stage of investigation into suspected anti-competitive practices.

At this point, not much else is known for sure. The company has not been found guilty of anti-competitive behavior and the duration of the investigation will depend on a range of factors, such as the complexity of the case and the extent to which the company cooperates with the Commission.

Press release

Other news:

The EMA Committee for Medicinal Products for Human Use has decided that a booster dose of Moderna Spikevax’s COVID-19 vaccine can be considered in people 18 years of age and older. EMA opinion

© 2021 Society of Regulatory Affairs Professionals.

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