IFPMA CPP Network Training Toolkit, Schemes and Mind Maps of Marketing

Download IFPMA CPP Network Training Toolkit and more Schemes and Mind Maps Marketing in PDF only on Docsity! Certification Scheme for a Certificate of Pharmaceutical Product (CPP) IFPMA CPP Network Training Toolkit 01 Training package Appendix - WHO CPP template 02 Why is training needed? IFPMA position papers and articles CPP overview CPP scenario training eCPP References and glossary Training modules 05 CPP Overview CPP Scenario Training eCPP Training Modules IFPMA Position Papers and ArticlesReferences and Glossary Appendix - WHO CPP Template CPP overview What is a CPP and what is its purpose? Which countries require a CPP and why? 06 CPP Overview CPP Scenario Training eCPP Training Modules What is a CPP and what is its purpose? Which countries require a CPP and why? IFPMA Position Papers and ArticlesReferences and Glossary Appendix - WHO CPP Template What is a CPP and what is its purpose? The WHO Certification Scheme for a Certificate of Pharmaceutical Product (CPP) is an international voluntary agreement to provide assurance to countries participating in the Scheme, about the quality of pharmaceutical products moving in international commerce. Guidelines are located on the WHO website www.who.int The CPP template (contents) are provided in the Appendix The CPP supports the review in countries without sufficient capability to conduct a full review themselves. Ideally, a CPP should not be required in countries that have the capabilities to conduct full reviews. The CPP should be used when a pharmaceutical product is under consideration for a product licence/marketing authorisation or when administrative action is required to renew, extend or vary such a licence. The CPP contains, but is not limited to the following information: Confirmation of approval of QSE in the issuing country, A snapshot of the licence (only includes information registered in the issuing country), Confirms product approval, licence holder and Good Manufacturing Practices (GMP) status. The Scheme ensures: The CPP Issuer meets a comprehensive system of quality assurance, Through independent inspection that all manufacturing operations are carried out in conformity with GMP. 07 CPP Overview CPP Scenario Training eCPP Training Modules What is a CPP and what is its purpose? Which countries require a CPP and why? IFPMA Position Papers and ArticlesReferences and Glossary Appendix - WHO CPP Template A CPP has two DISTINCT parts: Evidence of QSE Review. Evidence of Compliance with GMP. Refer to WHO for model certificate content (1) Content of the CPP * Refer to WHO guidelines (2) 10 CPP Overview CPP Scenario Training eCPP Training Modules What is a CPP and what is its purpose? Which countries require a CPP and why? IFPMA Position Papers and ArticlesReferences and Glossary Appendix - WHO CPP Template An effective national licensing system, not only for pharmaceutical products, but also for the responsible manufacturers and distributors; GMP requirements, consonant with those recommended by WHO, to which all manufacturers of finished pharmaceutical products are required to conform; Effective controls to monitor the quality of pharmaceutical products registered or manufactured within its country, including access to an independent quality control laboratory; A national pharmaceuticals inspectorate, operating as an arm of the national drug regulatory authority, and having the technical competence, experience and resources to assess whether GMP and other controls are being effectively implemented, and the legal power to conduct appropriate investigations to ensure that manufacturers conform to these requirements by, for example, examining premises and records and taking samples; and Administrative capacity to issue the required certificates and to institute inquiries in the case of complaint. In addition to notify expeditiously both WHO and the competent authority in any Member State, to have imported a specific product that is subsequently associated with a potentially serious quality defect or other hazard. Authorities issuing WHO-type certificates should satisfy the following criteria Which countries require CPPs and why? Countries within regions, for example: Latin America, Asia Pacific, Middle East/Africa, Eastern Europe / Commonwealth of Independent States (CIS). The CPP may be required to support a regulatory submission. This can be submitted at the beginning of, or during the health authority review. According to the WHO Scheme, CPPs should not be required in countries that require full ICH CTD dossiers and have the capability to conduct full QSE reviews. 11 CPP Overview CPP Scenario Training eCPP Training Modules What is a CPP and what is its purpose? IFPMA Position Papers and Articles Which countries require a CPP and why? References and Glossary Appendix - WHO CPP Template 12 CPP Overview CPP Scenario Training eCPP Training Modules IFPMA Position Papers and ArticlesReferences and Glossary Appendix - WHO CPP Template CPP scenario training 1 2 3 4 CPP applications and authority interpretation CPPs - a snapshot of the registration in the exporting country Legalization of US foreign exported CPPs CPPs and the registration process in importing countries 15 CPP Overview CPP Scenario Training eCPP Training Modules IFPMA Position Papers and Articles 2Scenario CPP applications and authority interpretation Scenario Scenario Scenario2 3 41 CPP applications are not harmonized Key ConsiderationsExercise Scenario References and Glossary Appendix - WHO CPP Template Work towards harmonization and a standard electronic submission, such as the approach with electronic Common Technical Document (eCTD). Harmonization among regulatory agencies will enable a faster, compliant and simplified issuing process. This could be achieved by the introduction of electronic CPPs (eCPP). Applicants should take care to provide correct information when requesting CPPs. Issuing HAs should be aware that the CPP issuing times can significantly impact registration timelines. Issuing HAs should ensure adequate communication to industry of changes to CPP application and/or issuing processes to make sure that all involved stakeholders are aware and prepared for implementation. Patient access to novel medicines will be enhanced by HAs willingness to accept CPPs during the review rather than at the time of submission. Key considerations 16 CPP Overview CPP Scenario Training eCPP Training Modules IFPMA Position Papers and Articles Exercise Scenario Key Considerations Scenario1 2 Scenario Scenario3 4Scenario CPPs - a snapshot of the registration in the exporting country References and Glossary Appendix - WHO CPP Template Country X requires a new product to be registered rapidly due to an unmet medical need. Country X HA has a legislative requirement to provide a CPP with the initial submission. To prepare in advance, country X sends the detailed requirements for the submission including the requirement for a CPP. The company’s regulatory team provides the CPP to Country X, based on the first approval, so that they can begin the submission procedure as quickly as possible. Country X soon recognises that they have an issue, as the CPP issued does not reflect the information that has been provided within the dossier (e.g. different manufacturing site), and the next approval that will match is not due for additional 6 months. How can the global regulatory submission team, HAs and country X work together to overcome this issue? Exercise scenario The CPP only reflects the approved manufacturing sourcing route of the certifying country Most recipient authorities expect that the drug product they will receive mirrors that which has been approved by the authority issuing the CPP. When developing a global submission strategy CPP requirements are considered early during the planning phase. If required HAs should be open to discussion in advance of the regulatory submission to give advice and agree on the content of the submission including the CPP to move forward as quickly possible. 17 CPP Overview CPP Scenario Training eCPP Training Modules IFPMA Position Papers and Articles Scenario1 2 Scenario CPPs - a snapshot of the registration in the exporting country Scenario Scenario3 4 Exercise Scenario Key Considerations References and Glossary Appendix - WHO CPP Template Key considerations The CPP only reflects the approved manufacturing sourcing route of the certifying country 20 CPP Overview CPP Scenario Training eCPP Training Modules IFPMA Position Papers and Articles 3 Scenario Scenario CPPs and the registration process in importing countries 4 Exercise Scenario Key Considerations Scenario2Scenario1 References and Glossary Appendix - WHO CPP Template Country X requires a CPP to be submitted as part of the initial registration dossier. During submission preparation it is noticed that the legislative requirements for the dossier consist of submitting a full ICH CTD dossier (Modules 2, 3, 4 & 5). It is not understood why the full ICH CTD dossier is being requested in addition to a CPP as, according to the WHO scheme, the CPP should replace the QSE review. Upon consultation with the HA of country X, it is explained that the CPP is required as reassurance of an approval by a stringent HA rather than to replace the QSE review. CPPs may no longer be accepted as a substitute for the full dossier QSE review 21 CPP Overview CPP Scenario Training eCPP Training Modules IFPMA Position Papers and Articles 3 Scenario Scenario CPPs and the registration process in importing countries 4Scenario2Scenario1 Exercise Scenario Key Considerations References and Glossary Appendix - WHO CPP Template Alternatives should be considered by the HA when they move to a full ICH CTD to overcome the inappropriate use of the CPP e.g. use of an approval letter or an assessment report. Increase flexibility in providing the CPP during the review or prior to approval, not at the time of submission, to enable earlier dossier submission and allow faster patient access to innovative treatments. According to WHO Scheme, CPPs should not be required in countries that require full ICH CTD dossiers and have capabilities of conducting full QSE reviews. However, CPP requirements are often legislatively driven and it necessitates legislative changes to remove this requirement. QSE evaluation 22 CPP Overview CPP Scenario Training eCPP Training Modules IFPMA Position Papers and ArticlesReferences and Glossary Appendix - WHO CPP Template Electronic CPP The electronic CPP - considerations for the future Future eCPP implementation 25 CPP Overview CPP Scenario Training eCPP Training Modules IFPMA Position Papers and Articles References Glossary References and Glossary Appendix - WHO CPP Template 1 2 3 References WHO model certificate of a pharmaceutical product Guidelines on the implementation of the WHO certification scheme Q&A for WHO Certification Scheme on the quality of pharmaceutical products, WHO Drug Information Vol. 30, No. 3, 2016 4 Proposal for revision of the Who Certification Scheme on the quality of pharmaceutical products moving in international commerce (draft) 26 CPP Overview CPP Scenario Training eCPP Training Modules IFPMA Position Papers and Articles References Glossary References and Glossary Appendix - WHO CPP Template Glossary www.ich.org CTD: Common Technical Document eCTD: electronic Common Technical Document EVMPD: EudraVigilance Medicinal Product Dictionary FDA: Food and Drug Authority GMP: Good Manufacturing Practices HA: Health Authority ICH: International Council of Harmonization IDMP : Identification of Medicinal Products IFPMA: International Federation of Pharmaceutical Manufacturers and Associations QSE: Quality, Safety and Efficacy TOPRA: The Organisation for Professionals in Regulatory Affairs MAH: Marketing Authorization Holder MAA: Market Access Authorization WHO: World Health Organization www.who.int www.topra.org www.ifpma.org www.idmp1.com 27 CPP Overview CPP Scenario Training eCPP IFPMA position papers and articles IFPMA Position Papers and ArticlesReferences and Glossary Appendix - WHO CPP Template IFPMA position papers and articles 1 4 US CPP paper Q&A View all documents Electronic CPP The WHO CPP Scheme in today’s regulatory environment – is it time for change? WHO Q&A How has the evolution of the global pharmaceutical market affected the use of WHO CPP? 30 CPP Overview CPP Scenario Training eCPP Appendix - WHO CPP Template IFPMA Position Papers and ArticlesReferences and Glossary Applicant for certificate (name and address)2.B.1. Status of applicant 2.B.2. For categories (b) and (c) the name and address of the manufacturer producing the dosage form is… 2.B.2.1. Why is marketing authorization lacking? (not required/not requested/under consideration/refused) 2.B.3. Remarks2.B.4. Appendix - WHO CPP template (cont.) 31 Appendix - WHO CPP template CPP Overview CPP Scenario Training eCPP Appendix - WHO CPP Template IFPMA Position Papers and ArticlesReferences and Glossary 3. Does the certifying authority arrange for periodic inspection of the manufacturing plant in which the dosage form is produced? (yes/no/not applicable) If not or not applicable, proceed to question 4. 3.1. Periodicity of routine inspections (years) 3.2. Has the manufacture of this type of dosage form been inspected? (yes/no) 3.3. Do the facilities and operations conform to GMP as recommended by the World Health Organization? (yes/no/not applicable) 4. Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product: (yes/no) If no, explain Address of certifying authority Telephone Fax Name of authorized person Signature Stamp and date