he World Health Organization (WHO) Certification Scheme on the quality of pharmaceutical products moving into international commerce, in effect since 1969, is an international voluntary agreement to provide assurance to countries participating in the Scheme about the quality of pharmaceutical products. The primary document of the Scheme is the Certificate of Pharmaceutical Product (CPP). Since its inception, the Scheme has undergone revisions (most recently, in 2021) to adapt to the changing global regulatory environment, including the rapid globalization of the pharmaceutical manufacturing sector. In this article, voices from regulatory authorities from three different regions explain how they have been adapting their CPP-related practices while ensuring that this Certificate retains its usefulness and supports more efficient regulatory decision-making.
The CPP as a shortcut to access to new drugs that provide significant benefits for life-threatening or severely debilitating diseases in Hong Kong
By Lot Chan, Department of Health of the Government of the Hong Kong Special Administrative Region
The WHO Scheme proposes that the CPP is intended to facilitate the trade of pharmaceutical products, and that its use should have a positive impact for regulators in terms of quality and time spent assessing dossiers for marketing authorization. The Scheme is intended to facilitate reliance among participating authorities, and its use should enable a timely access to medicines. One of the regulatory authorities using the CPP as a reliance tool is the Pharmacy and Poisons Board of Hong Kong (PPBHK), where it serves as evidence of a robust assessment, reducing the time to market for pharmaceutical products.
In accordance with Hong Kong’s legislation, all pharmaceutical products must meet the criteria of safety, efficacy, and quality, and undergo registration with the PPBHK before they are allowed for sale in the market. When evaluating a product for registration, the PPBHK considers the registration status and assessment result of the product in other jurisdictions, particularly by those national regulatory agencies that are regarded as “stringent” or “mature” regulatory authorities. The CPP issued by these regulatory authorities contains crucial information regarding the product’s composition, marketing status, and manufacturer’s Good Manufacturing Practices (GMP) compliance. This information substantiates that the pharmaceutical product has gone through rigorous assessment of its safety, effectiveness, and quality by the drug regulatory agency of the country of origin for marketing authorization.
Under good reliance practice, Hong Kong gives significant weight to the assessment conducted by drug regulatory authorities of “reference countries” recognized by the PPBHK. This approach optimizes resources by avoiding the need for exhaustive assessments of all nonclinical and clinical data and, in most cases, eliminates the need for inspections of manufacturers outside Hong Kong. Consequently, this enhances the efficiency and cost-effectiveness of the evaluation and approval procedures.
Previously, applicants for registration of innovative drugs had to provide CPPs from a minimum of two “reference countries” along with other necessary documentation. Since November 2023, Hong Kong has implemented the “1+” mechanism for new drugs registration to further streamline the approval process with the purpose of providing early access to safe and efficacious medicines for patients. Under the “1+” mechanism, applicants can seek registration for new drugs that provide significant benefits for life-threatening or severely debilitating diseases. This can be done by submitting local clinical data and a recognized scope of application, supported by a CPP from a single reference drug regulatory authority, instead of two. This new mechanism facilitates the registration process for groundbreaking pharmaceuticals addressing unmet medical needs in the local population by shortening the waiting time for obtaining a second CPP.
The introduction of this mechanism has generated significant interest from industry. Since the introduction of the “1+” mechanism, numerous inquiries have been received and three products have been successfully registered using this mechanism as of the end of July 2024. While Hong Kong will maintain the registration pathway based on CPP issued by reference drug regulatory authorities, the “1+” mechanism also serves as an interim measure toward the goal of conducting its own evaluations based on full nonclinical and clinical data on a drug, thereby improving the new drug registration pathway and promoting medical innovation.
Modernizing the regulatory framework and strengthening reliance practices with the elimination of legalization requirements and the use of electronic CPPs in Egypt
By Asmaa Fouad, Egyptian Drug Authority
According to regulations established by the Egyptian Drug Authority (EDA), a CPP is a mandatory document required for the registration of any imported product. This requirement applies to new product submissions, specific variations, and renewals, with the CPP needing to be submitted at the beginning of the review process.
Nevertheless, in response to the challenges posed by the COVID-19 pandemic, EDA had to quickly adapt their procedures to maintain the efficiency of its drug registration processes. With global lockdowns and restrictions on physical interactions, many authorities began issuing CPPs with electronic signatures (eCPPs). Recognizing the need for flexibility and speed during the pandemic, the EDA updated its legislation to accept the eCPP, reflecting the agency’s commitment to staying aligned with the evolving landscape of global health regulations.
Prior to this change, the EDA required the submission of an original legalized CPP. Recognizing that the legalization process added unnecessary time without enhancing the value of the CPP, since it only confirmed the signatures, not the content, the EDA decided to update its regulations. The EDA’s new regulations eliminated the requirement for original legalized CPPs, allowing for the submission of eCPPs instead. This transition was based on the premise that the authenticity of the eCPP could be verified directly with the issuing authority through their validation tools.
The EDA took proactive steps to ensure a smooth transition, sharing that the process was straightforward from their perspective. This update was promptly communicated to applicants via an announcement on the EDA’s official website, signaling the agency’s readiness to embrace digital solutions.
The shift to accepting eCPPs has resulted in more flexible regulations, making the registration process better adapted to the needs of the pharmaceutical industry. This change has demonstrated the EDA’s ability to respond to global challenges with agility, ensuring that the registration of pharmaceutical products in Egypt continues smoothly, even in times of crisis. Also, the reduction in paper submissions improves the work environment and supports broader sustainability efforts. The agency’s adoption of eCPPs underscores its commitment to modernizing its regulatory framework and strengthening its reliance practices. This shift allows for more efficient resources and time allocation, benefiting the regulatory agencies, pharmaceutical industry, and the public health.
Ensuring timely availability of medicines in Cuba and beyond: CECMED’s commitment to implementing flexibility for issuing and receiving CPPs
By Celeste Sanchez, Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos, Cuba
The CPP is a requirement for marketing authorization established in the country’s regulations for both imported and exported products since Cuba’s incorporation without reservations into the WHO Certification Scheme, which occurred in June 1997. CECMED was declared as the national regulatory authority in charge of both issuing CPPs for products manufactured and registered in Cuba, and for receiving CPPs that will support the assessment for regulatory approval of products manufactured abroad. During the past several years, the agency has been involved in global and regional activities related to updating the WHO Scheme and its adaptation to the new pharmaceutical environment, by virtue of which it has adopted a set of good practices which allow for more efficient regulatory performance.
As a certifying authority, CECMED is committed to delivering the Certificates under the best possible conditions. Issuing CPPs takes no longer than 10 business days, and the documentation can be in Spanish, the official language in Cuba, or in both Spanish and English, with the intention to avoid unnecessary translations, thus preventing further delays in the use of these Certificates during the receiving authority’s regulatory assessments. Another practice adopted by CECMED is the declaration of the name of the product outside the country: If the brand name that will be used for the product abroad is different from the one used in Cuba, it is included in the Certificate as declared by the applicant that requested the CPP. The Cuban regulatory agency also provides full access to the information related to marketing authorization on its website, allowing the receiving authority of a CPP to easily verify the information of the Certificate whenever doubts emerge.
In parallel, CECMED continues to work to optimize its practices as a CPP-receiving authority, to adhere to some of the improvements and flexibilities recommended by the latest WHO guidelines on the implementation of the WHO Certification Scheme. One of these flexibilities is that CECMED accepts alternative documentation (such as approval letters and GMP certificates) to replace the CPP, when the Certificate is not readily available at the moment of the submission. Other areas for improvement have already been identified, and the regulator is currently working on implementing the most appropriate solutions; these include the acceptance of electronic signatures and the full list of names and addresses of manufacturing sites in CPPs issued by CECMED; the elimination of the legalization requirement for the Certificates required by the authority is currently under discussion.