he WHO Certification Scheme for CPP, an international voluntary agreement that provides assurance about the quality of pharmaceutical products moving into international commerce to countries participating in the Scheme, was established in the 1960s as one of the first regulatory reliance tools.

Samvel Azatyan (SA): Reliance is a very popular concept today, but it is not a new concept at all. It has existed, at least in the WHO context, since the 1960s when the certification scheme was proposed. The WHO Certification Scheme for pharmaceutical products moving in international commerce, otherwise known as the CPP Scheme, is recognized as the first regulatory reliance tool. The CPP scheme was intended to facilitate international trade in pharmaceuticals, or medical products in general, and to first ensure product quality, but also safety and efficacy. As I mentioned, it is considered a reliance mechanism.

CPP offers participating WHO Member States, especially those with (unfortunately) limited regulatory capacity, assurance that the product entering their markets corresponds to specific quality standards as certified by the regulatory authority of the exporting country or by the certificate-issuing authority.

Since the 1960s, the world has evolved quite dramatically and the whole regulatory landscape has changed. There are some situations where there is added value from the CPP, and some situations where it should not be used or required. The challenge is that we should be absolutely clear about legal requirements for using CPP. It’s not up to individual experts in regulatory authorities whether to use CPP. It is quite often in their regulatory requirements. Sometimes even regulatory experts recognize that they could easily survive without requesting CPP. But it is in their regulatory requirements, so they request it.

We can say when the CPP should be used from the WHO point of view: It gives added value when the regulatory authority of the importing country lacks the resources or capacity to conduct full product assessment on their own, independently. In this case, their reliance on a CPP will allow for a more efficient use of their sometimes very scarce resources to maintain high regulatory standards and efficiency, and it will also play a very important role in accelerating access. We are concerned about access to essential medicines and other medical products, especially in low- and middle-income settings.

On the contrary, CPP should not be required in situations where the country has sufficient regulatory capacity and expertise to conduct their own assessments or when the product is manufactured under the oversight of some stringent regulatory authority or, as now we call them, WHO-listed authorities (WLAs). The importing country already recognizes them as reference authorities and can rely upon the decisions or information available from these countries. Additionally, requiring a CPP may not be necessary for products where there are established international or regional regulatory cooperation mechanisms, such as mutual recognition agreements, already in place.

SA: The COVID-19 pandemic dramatically changed the overall regulatory culture. Some things which were considered impossible suddenly became possible. This includes eCPP and other electronic means or digital processes in the regulation of medical products. COVID-19, with all its problems, was also very educative for the global regulatory community.

WHO strongly encourages the adoption of digital regulatory processes and technologies, including the use of electronic CPPs and electronic certificates, and this move towards digitization, including the use of electronic signatures and other forms of electronic documents, is perfectly in line with broader WHO efforts.

WHO issued very clear recommendations to our Member States’ national regulatory authorities for the use of electronic documentation, including eCPP.

We believe that national regulatory authorities should put more effort into developing robust, modern electronic systems which could help ensure the security, authenticity, and traceability of eCPPs because the recipients are most concerned with the safety of their information and about compromising the integrity of their information when it is shared electronically. This is a critically important element of our work, and these systems should be compliant with all international standards for electronic documentation and signatures. Transparency in these eCPP issuance processes is also a key for building the trust which is essential for proper implementation of regulatory processes.

We expect that national regulatory authorities receiving eCPPs should also implement in-house systems to verify the authenticity of certificates issued electronically. Many have their history and memory of the former paper-based system when anyone could fabricate a fake certificate, even put the WHO logo on it, and send it by fax. This was causing a lot of confusion and lack of trust throughout the system. Somehow, we trust electronic signatures in our banking systems. We trust that system to handle all our personal financial resources. But for some reason, we don’t want to trust electronic signatures on certificates. This is also something in the overall regulatory culture and mentality that needs to change. We are optimistic that this will change based on robust electronic systems which verify the authenticity of eCPPs. By transitioning to eCPP, national regulatory authorities can enhance their overall efficiency. This is the expectation of the public. They also can reduce administrative burden and ensure quicker access to medical products, as is expected by our Member States.

SA: This is a very important question. The majority of our Member States have small or very small regulatory authorities. Only a small percentage of our Member States have a big and well-established regulatory authority. Those who are small or very small have the same mandate and same responsibilities as the big ones, but they have to implement this mandate, this responsibility, with sometimes 100 times less staff and resources available. The resources in smaller countries are sometimes not enough to address their daily needs, while implementing modern electronic systems requires substantial resources. Modern electronic solutions are sometimes expensive, including the cost of initial development but also the maintenance of licenses and so on.

Cost is not always the only obstacle. Some agencies which are relatively well established in terms of resources still have an emotional barrier to accepting this electronic means because of a lack of trust. Some countries have very strict requirements which do not allow for their information to be stored outside their jurisdictions. Human beings are by nature conservative, and it’s quite difficult sometimes to accept something new. It’s not always the issue of resources, but of willingness to change.

SA: On this topic, we also have a very clear policy and position: WHO’s position is that an eCPP, when issued by a recognized NRA, already adheres to international principles and standards which are endorsed by many of our Member States. As such, the additional requirement for further legalization—such as consular authentication—often adds unnecessary administrative complexity, extra costs, and delays, without improving the reliability of the document itself.

WHO convinces our Member States’ NRAs to trust and rely on the authenticity of a CPP or eCPP as issued by the exporting country’s competent authority. WHO also encourages further dialogue between NRAs to clarify and address concerns about authenticity in a way that avoids excessive bureaucracy and fosters greater reliance on validated and trusted digital systems.

SA: As I mentioned, the world is not the same as it was back in the 1960s. The introduction of the internet was a fantastic milestone, a game changer, and now information exchange is easy and swift, with all possible positive and (sometimes) negative consequences.

We understand and acknowledge the need for CPP, including eCPP, to evolve. It cannot be a static instrument. It should be a dynamic instrument, and this is what we are doing with the CPP scheme. We revise the scheme on a regular basis based on requests from our Member States. These requests are based on the changing regulatory environment and its growing emphasis on reliance and cooperation among national regulatory authorities.

Cooperation is becoming reality. There is almost no NRA that is not involved in one or another regulatory harmonization, convergence, or work-sharing initiative. The same with CPP and eCPP. It is a long-standing tool, existing for decades now, but it has the potential to support much better global regulatory efficiency by integrating with newer regulatory reliance initiatives. The work-sharing arrangements and joint activities organized between different regulatory authorities are a reality. We have various regulatory harmonization efforts and initiatives implemented in different parts of the world, at global and regional levels.

Looking ahead, WHO is exploring areas for potential improvement of the CPP Scheme. One important thing is broader integration: Strengthening the role of CPP with regulatory reliance pathways and aligning with regional and global regulatory reliance initiatives and frameworks such as the WLA framework, which is strongly promoting reliance as a concept.

The second potential area is interoperability and data integration. We need to enhance digital platforms to ensure that CPP systems can be interoperable across borders to enable smoother, faster regulatory processes. Potential linking of the CPP/eCPP with other global regulatory databases, such as WHO prequalification and international reference standards, may provide a more comprehensive and transparent approach to regulation of medical products.

In this context, CPP will maintain its place and add value to overall regulatory efficiency. Continuing to modernize CPP or eCPP aims to further contribute to a globally harmonized and efficient regulatory environment, and this ultimately will improve access to medical products for all people.

SA: We should be a bit patient in understanding the situations where low- and middle-income country regulators live. It’s easy to blame them, that they are not willing to accept change or not willing to modernize. Quite often, it’s not in their hands, and regulators are obliged to implement the existing requirements whether they are good or not.

Changing regulatory requirements, and especially regulatory legislation, is a very difficult task. It sometimes takes decades for countries to change their pharmaceutical legislation. In some countries, these issues related to CPP are in their high-level pharmaceutical legislation and no one dares touch it.

It takes time, effort, and resources. This is why WHO also invests in capacity building, advocacy, and sensitization. Just this year, we organized three or four webinars focused on advocacy and sensitization for the CPP, aimed at improving its implementation. These initiatives are designed to help transform the overall regulatory culture, which ultimately contributes to better access to essential medical products.