he Certificate of Pharmaceutical Product (CPP) is a document issued by a regulatory authority at the request of a product owner to support the registration process of that pharmaceutical product by another regulatory authority in a different country. Historically, one of the most in-demand CPP-issuing authorities has been the European Medicines Agency (EMA).

In this interview, Alberto Ganan Jimenez, Head of Committees and Quality Assurance Department at the EMA, shares the transitional journey from paper-based CPPs to electronic CPPs, including lessons learned, recommendations, and insights from the European experience.

DIA: What prompted this transition? What are the key benefits of this electronic format, the eCPP?

Alberto Ganan Jimenez (AGJ): Digital transformation is a key priority area in the European Union and its institutions. The implementation of the electronic certificate (eCPP) was part of the EMA’s drive for digital transformation, increased efficiency, and our commitment to “go green.”

Although the agency had explored the possibility of developing an eCPP before 2020, the COVID-19 pandemic ultimately prompted its immediate implementation. This ensured that EMA could provide certificates during the COVID-19 pandemic without any business disruption, facilitating regulatory compliance and timely access to medicines in importing countries.

This new format has brought significant benefits at various levels: the digital format and the electronic signature better ensure the integrity and authenticity of the certificate because any manipulation can be detected. It also enables a faster distribution among the agency, applicants, and receiving authorities.

DIA: What were the main policy and operational challenges for EMA in this transition?

AGJ: The eCPP is fully compatible with the WHO certification scheme, and its implementation was strongly supported by WHO.

The main challenges came from the required adaptations of internal processes, systems, and policies (e.g., the fee scheme) at EMA. An important aspect was the selection of a trusted provider for the electronic signature to ensure full compliance with the strict requirements of European legislation for electronic transactions (eIDAS Regulation). Our experience was positive because the agency was able to implement all of these changes within 10 days.

The timely publication of specific guidance on the new format of eCPPs and the targeted communication campaigns to relevant stakeholders, such as the industry and the authorities of importing countries, were key for the successful implementation and prompt acceptability of the new format by the receiving authorities.

DIA: In 2022, EMA developed and launched an online verification system for the eCPP. What is it, and what drove the need for EMA to develop it?

AGJ: The online verification system for EMA eCPPs available on the EMA website was launched to support the health authorities of importing countries and any interested parties to verify the authenticity of an electronic certificate issued by EMA.

Each eCPP has two unique identifying numbers. When they are entered in the appropriate fields, the tool displays certain details of the eCPP, including the name of the signatory and a confirmation that the eCPP has been issued by the agency.

The electronic signature and the safety features guarantee the integrity and authenticity of a certificate. Our driver to launch this system was to provide full reassurance that the eCPP was issued by EMA and is valid.

DIA: The EMA eCPP is an important part of regulatory submissions all around the globe. What measures has EMA taken to support global implementation of eCPP, and what challenges have you encountered?

AGJ: EMA pioneered the implementation of eCPPs globally. Although EMA is a leading authority in issuing certificates, worldwide success of the eCPPs depends on international support from WHO, other authorities adopting a similar approach, and recipient authorities having the necessary legal and technical frameworks to recognize them.

Good and effective collaboration with WHO, other regulatory bodies, and industry was crucial for the early rollout of eCPPs. We shared our experiences with other leading authorities considering issuing eCPPs and engaged actively with authorities in importing countries facing challenges in accepting them. Additionally, we embarked on an active communication campaign in international forums, dedicated webinars, letters, promotional materials, and social media campaigns.

We are delighted that EMA eCPPs are now broadly accepted by regulatory bodies in importing countries. Numerous receiving authorities have made the required legal and technical adjustments in their national regulatory systems to accept eCPPs.

DIA: Can you share any statistics about the number of CPPs the EMA has issued: a total, or annual average, or something similar?

AGJ: EMA issues more than 11,500 eCPPs every year, which are addressed to around 145 importing authorities worldwide. Since its implementation in March 2020, we have issued more than 57,000 eCPPs. We offer two services: urgent eCPPs (issued within two [2] working days) and standard eCPPs (issued within ten [10] working days).

DIA: What is EMA’s position on the legalization or apostillation of eCPP, as requested by some international regulators? Are you interacting with other national regulators on this topic?

AGJ: This requirement is not supported by WHO and EMA as it is considered unnecessary. The eCPPs and the EMA online tool are more than sufficient to ensure integrity, authenticity, and validity. I am very glad that some importing countries have eliminated this requirement while updating their legal frameworks to accept eCPPs.

DIA: If the format of the data described in the eCPP is different from other EMA data systems, what can regulators and sponsors do in case they experience difficulty or have questions?

AGJ: Adhering to common standards and quality criteria is essential for reusing regulatory data for global submissions. EMA is gradually implementing the ISO IDMP standards focusing on four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) data.

Currently, some data in CTD dossiers and databases may not fully conform to these standards, leading to minor discrepancies. For instance, the same manufacturing site’s address might be expressed differently in CTDs and different databases.

The EU regulatory authorities aim to standardize data in regulatory submissions and databases to align with ISO IDMP standards and SPOR master data, including eCPPs. Sponsors or importing authorities with questions about the data included in eCPPs can always contact the EMA certificates team at certificate@ema.europa.eu for any clarification needed.

DIA: What are EMA’s messages and recommendations for regulators who hesitate to accept an eCPP, or who request that further information be included in the eCPP beyond the WHO definition of its format and content?

AGJ: As the world becomes more digital, regulatory agencies should update their frameworks to accept eCPPs and electronic submissions.

The WHO certification scheme defines the format and content of a CPP to ensure the quality of pharmaceuticals in global trade. This recommended format and content were extensively discussed and agreed with the participation of exporting and importing authorities. It is widely accepted by the participating members of the scheme. EMA fully supports the scheme and believes the recommended format and content are sufficient to support the quality of medicinal products.