Industry weighs in on the EU’s pandemic-related flexibilities

Europe’s successful experience with regulatory flexibilities during the pandemic provides lessons that can be brought to future modernization of the pharmaceutical regulatory framework, according to a team of industry regulatory experts. Flexibility on variations, language and labeling, change management, and good manufacturing practice (GMP) were all seen as highly valuable in a survey of industry.

Writing in the journal Therapeutic Innovation & Regulatory Science, Kevin Klein, of Amsterdam-based Exon Consultancy and coauthors gave a first peek into the perspective of European industry on experience with pandemic-related life sciences regulatory flexibilities. Vaccines Europe, separately, is focusing on vaccine development in Europe in a separate study, so vaccine-related flexibilities were not included in the paper’s analysis.

Two electronic surveys were disseminated, one looking broadly at pandemic-related flexibilities and one looking only at the value of flexibilities in support of COVID-19 therapeutic development. This latter survey was only sent to members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) who played a part in developing COVID-19 therapeutics.

The study looked at COVID-19 pandemic-related regulatory flexibility for research and development-oriented pharmaceutical companies in two main areas: flexibilities to assure that the supply of medicines is not interrupted, and regulatory flexibilities and “other measures” to support COVID-19 therapeutic development.

Although companies could only submit one response, they were encouraged to solicit input from expert internal stakeholders.

To address both objectives of the study, the survey asked respondents about the following guidance documents and regulations:

Notice to stakeholders: Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic (Rev. 3)
CMDh Practical guidance (CMDh/418/2020, Rev. 1)
Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic (Version 4 from July 2021)
Regulation (EU) 2020/1043 (July 2020)

The survey and objective aimed more specifically at COVID-19 therapeutics asked respondents about a different set of initiatives:

Mandate, objectives and rules of procedure of the COVID-19 EMA pandemic Task Force (COVID-ETF)
EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines
Labelling flexibilities for COVID-19 therapeutics
FDA/EMA common commentary on submitting an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP) for the prevention and treatment of COVID-19

For each individual instance of flexible regulation or guidance, respondents were asked to rate usefulness on a four-point Likert scale from “no value” to “significant value.” Respondents could also respond “don’t know.”

Six weeks’ time was allowed for responses, which were collated and blinded by individuals not involved with an EFPIA member company.

“The regulatory flexibilities on variations (A1.1) and on language and labelling (A1.4) scored highest in this section with 38% and 31% of the responses respectively indicating significant value and the majority of the remaining responses indicating some value,” wrote Klein and coauthors. Respondents did point out that the lack of harmonization among EU member states limits some of these flexibilities, though.

Klein and colleagues called out the Exceptional Change Management Process (ECMP) as being particularly high-value, if it continues beyond the pandemic, though respondents called for a simpler process and a broader scope.

Respondents had varying opinions about the utility of flexibilities related to clinical research, though adjustments related to direct-to-patient delivery, remote source verification and genetically modified organisms were, overall, assessed as the most important flexibilities in this area.

Regarding pharmacovigilance flexibilities, respondents were overall lukewarm, with an average assessment of 2 (“some value”) for these adjustments.

In the comments, respondents highlighted that e-labeling and other electronic modernization efforts are needed. Industry would generally welcome continuing to have virtual meetings with the European Medicines Agency (EMA), and would also find an EU-wide emergency use authorization procedure useful. Some bemoaned the still-slow pace of EMA activities in comparison with other major global health authorities.

Quality- and supply-related flexibilities were seen as highly useful by respondents, receiving the highest number of “significant value” scores. None of these flexibilities were seen as having “limited value” or “no value.”

EFPIA was involved in producing the paper. In a press release, the trade association reinforced some key messages for industry and regulators. “The study records that the regulatory flexibilities provided successfully served to address critical needs for clinical research, licensing, manufacturing and supply during the pandemic,” wrote EFPIA. “Moreover, the findings also indicate that many flexibilities are foreseen to have value beyond the pandemic, particularly where the EU/EEA and its Member States collaborate and align to deliver a single, streamlined regulatory framework.”

Some of the “clear drivers” for success include a move toward increased digitalization, as well as willingness to adopt regulatory innovations such as rolling reviews and the flexible delivery of scientific advice, EFPIA said.

Isabelle Stoeckert, vice president of regulatory affairs for EMEA at Bayer AG, serves as chair of EFPIA’s COVID-19 rapid response team. Stoeckert, a study co-author, pointed out that the paper presents one of the first evidence-based reviews that go through the pandemic’s regulatory flexibilities in detail.

“We believe that these findings should inspire us to go further in Europe,” said Stoeckert. “EFPIA believes that the most impactful flexibilities signal where we need to go further to deliver a step change in faster, more equitable access to medicines for patients and ensure that Europe can be at the forefront of the development of the next generation of diagnostics, treatments and vaccines.”

Therapeutic Innovation & Regulatory Science

Industry weighs in on the EU’s pandemic-related flexibilities

Related topics

Recommended content

Welcome to the new RAPS Digital Experience