he need for regulators to ensure business continuity, make fast and informed decisions, and adapt to a digital environment has driven the adoption of various digital technologies and solutions to enhance regulatory processes. This rapid adaptation and use of digital technologies by regulators was accelerated during the unparalleled challenges posed by the COVID-19 pandemic. In this context, the Certificate of Pharmaceutical Product (CPP) was no exception, leading to the advent of the electronic CPP (eCPP). However, an industry survey shows that many regulators are not currently in the position to use this eCPP, a problem that causes unnecessary delays in the regulatory assessment process.

In 2020, the European Medicines Agency (EMA) started issuing eCPPs driven by the need to adapt to the limitations imposed by the pandemic, but also as part of the broader modernization of the European systems. This EMA decision prompted regulators around the globe, many accustomed to receiving paper documentation, to adjust their local practices to work with electronic Certificates. This adaptation has been an ongoing and evolving process, reflecting the overall shift towards digitalization of regulatory practices.

Industry Partnership

Industry and other stakeholders are convinced that the eCPP is a solution that should be widely implemented. The use of eCPPs can improve the speed and efficiency of regulatory processes, more easily overcome trade disruption, and streamline the verification and authentication process of these Certificates. Other advantages of electronic documents lie in the potential to further promote trust amongst regulators and regulated parties, modernize and harmonize administrative contents, and simplify regulatory processes.

In 2021, in line with the objective of providing valuable data for monitoring the evolution and challenges with the global use of EMA’s eCPP, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) began a partnership to gather information from member companies on their experience with eCPP adoption and use around the globe. Since then, IFPMA and EFPIA have shared these results with regulators, the World Health Organization (WHO), and industry, culminating in a dedicated webinar to present and discuss the topic at length. The results of these data-collection exercises have also been shared with the EMA and enabled their understanding of the global acceptance of their eCPPs, informing educational and outreach activities from European regulators towards health agencies that use their Certificates to inform local regulatory decisions.

The most recent data collection exercise was deployed between August and December 2023, when a task force composed of members from EFPIA and IFPMA compiled the input received from 22 pharmaceutical companies, covering 105 countries, to shed some light on the experience and industry perception of the global acceptance and use of EMA eCPPs. This data was collected using an electronic survey, and the sections below detail its most relevant findings.

Global Acceptance of EMA’s eCPP: Main Findings

As of 2023, the company experience reflected in the survey indicated that the EMA eCPP is accepted by 95% of the 105 countries that participated. Among them, 46% accepted its original electronic format, while 49% accepted the eCPP, but required it to be printed and presented as a hard copy. Even though this number indicates an evolution from the initial 88% (out of 80 countries) in the data collected in May 2020, it also shows how most regulators are not yet in a position to use the EMA’s eCPP in its electronic version. When justifying the reasons for the nonacceptance of the eCPP or the need to provide paper copies, most companies argued that either the regulatory authority is not in a position to handle electronic documentation, or that the local regulations require documents to be printed because of the need to subject them to legalization or apostillation.

In fact, data from the same 2023 survey indicated that, according to company experience, 57% of countries always require the CPP to be legalized or apostilled. The notarization or embassy legalization of documents—replaced by the apostillation for countries that have ratified the 1961 Apostille Convention as part of the Hague Conference on Private International Law (HCCH)—are document authentication processes. According to the Guidelines on the implementation of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, these traditional legal methods are highly discouraged in the context of this WHO Certification Scheme, because they have caused undue delays in generating and processing documentation, without representing any value added to the regulatory assessment process. (See related article: “Minding the Gap: CPP Utilization Practices and the Impact on Submission Gap in Growth and Emerging Markets.”)

Further, the survey also clearly showed that industry experience highlighted that, in at least 17% of the countries, the regulator is using the EMA verification tool as a substitute to legalization or apostillation. This is the idea behind EMA’s systems to verify the authenticity of the eCPP, aimed at accelerating regulatory submissions across the world.

Looking Ahead

The recent procedures adopted by the EMA—namely the implementation of the eCPP and the creation of the EMA online authenticity verification system—reflect growing interest by regulators in adopting the eCPP to further promote timely access to medicines and vaccines. At the same time, the new digital solutions being implemented by reference regulators call for further reflection on the need to adapt local practices to new ways of working, to rationalize and streamline the use of CPPs, and to align local procedures to international best practices.

The challenge is how to reconcile these needs with the fact that most CPP-relying countries have limited regulatory capacity and resources; this can be an obstacle to implementation and use of electronic documentation and digital technologies. Additionally, in many countries, regulators might not be in a position to waive or change local requirements—including the requirement for wet signatures, legalization, or apostillation—which are described in local law.

This survey was developed because industry firmly believes that the implementation of electronic certificates will support the increase in efficiency of regulatory systems and is committed to support positioning the eCPP as a recognized and trusted tool for all stakeholders to ultimately facilitate faster access to medicinal products to patients.