Request for Proposals - Regulatory project

Request for proposals – Regulatory project

Objective

To create a database for regulatory requirements of generic pharmaceutical products in different low-income countries (LICs), lower-middle-income countries (LMICs) and upper-middle-income countries (UMICs); covered by MPP licences.

About the Medicines Patent Pool

The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries.

Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups and other stakeholders, to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.

To date, MPP has signed agreements with eleven patent holders for thirteen HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a long-acting technology and an experimental oral antiviral treatment for COVID-19. In 2020, MPP’s mandate was temporarily expanded to include COVID-19 treatments. In 2021 it was expanded further to include the licensing of technology with an initial focus on COVID-19 vaccines and pandemic preparedness.

MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC). MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government and SDC.

Consultancy purpose

Through this database, MPP intends to have a clear understanding of the following aspects related to registration of pharmaceutical products in different low-income countries (LICs), lower-middle-income countries (LMICs) and upper-middle-income countries (UMICs); covered by MPP licences

  • The general requirements for registration and /or import of products in the countries of interest
  • The different pathways for registering generics, complex generics, biosimilars, vaccines, and in vitro diagnostics (specific classes)
  • The requirements of data package support required from originators
  • The acceptability of SRA originators/dossiers for different national regulatory authorities
  • The different regulatory bodies that the country is a part of
  • The possible bioequivalence and biowaiver opportunities in the country
  • Any country specific requirements regarding originators, bioequivalence, clinical trials etc
  • The requirements for new formulations of existing molecules like long acting, new strength, new dosage form, fixed dose combination, multipurpose combinations, paediatric formulation etc

Scope:

The scope of the project would include a list of LICs, LMICs and UMICs as per Annexure.  Scope would include registration and/or import requirements of pharmaceutical products in the country of interest. Pharmaceutical products would include generics, complex generics, biosimilars, follow on vaccines, and In vitro diagnostics (specific classes).

Key Steps:

Stage 1

Conduct a mapping exercise to segregate the list of countries into two broad categories:

  • Countries which do not have an internal assessment procedure for generics and rely on assessment by other regulatory bodies: Group 1
  • Countries which have an internal assessment procedure for generics: Group 2

Conduct similar exercise for other categories like biosimilars, follow on vaccines, in vitro diagnostics

Stage 2

Database to be created for the companies in Group 1 and 2 to cover the following topics as enumerated below.

Group 1: Countries which do not have an internal assessment procedure

Database should focus on understanding the requirements of procurement procedure and import of pharmaceutical products. It should also identify the country’s inclusion into any regulatory body/group for filing. The database should provide answers to the following questions:

  1. What are the different Stringent Regulatory Authorities (SRAs) which are recognised by the country?
  2. Does the country participate in any other regulatory processes (WHO CRP, ASEAN, SADC, ZAZIBONA, CARICOM, AMRH, EAEU etc) through which a registration can be done?
  3. What are the documents required for import and registration of drug products (CoPP, GMP certifications etc)?
  4. Can any drug product be imported or there are any specific criteria, for eg inclusion in National Essential Medicines list?
  5. What are the stability data requirements for drug product?
  6. Is it necessary to have a local presence or can any manufacturer register their products in the country?
  7. Are there any special requirements with respect to local language usage for labelling?
  8. Are there any legislative timelines for registration of products?
  9. What are the fees for registration?

Conduct similar exercise for other categories like biosimilars, follow on vaccines, in vitro diagnostics.

Group 2: Countries which have an internal assessment procedure

In addition to the questions for group 1, database should also focus on understanding the local requirements for registration of pharmaceutical products. It should identify the regulatory guidance documents related to development and registration of generic pharmaceutical products. The database should provide answers to the following additional questions:

For generics/complex generics

  1. What is the regulatory guidance available for development and registration of generics? Are they available in English?
  2. Is there any specific requirement for choice of originator product?
  3. What are the additional data required if the originator is not present in the country?
  4. Is there any specific bioequivalence requirement (Choice of originator product, inclusion of local population etc)?
  5. Is BCS based biowaiver as per ICH M9 applicable? Apart from ICH, is there any additional data requirements?
  6. Is biowaiver applicable based on dose weight proportionality? What is the data package required for submission?
  7. Is there any specific guidance for establishing bioequivalence of complex generic products (Long acting injectables including microarray patches, device-based inhalation products, implants, vaginal rings etc)?
  8. What are the additional data required for new formulation/dosage/strength of existing molecule?
  9. What are the additional data required for new formulation /dosage form of existing molecules in paediatric population?
  10. What is the additional data requirement for multipurpose use combinations of existing molecules?
  11. Are there any specific requirements for raw materials like APIMF, excipients, packaging material etc?
  12. Is there any requirement of in-country QC release, testing or samples?
  13. Is there any requirement of separate GMP inspection?
  14. Are there any legislative timelines for registration of products?
  15. What are the fees for registration?

For biosimilars

  1. What are the regulatory pathways available for registration of biosimilars?
  2. What is the regulatory guidance available for development and registration of biosimilars? Are they available in English?
  3. Are there any special criteria for establishing biosimilarity apart from the guidelines from WHO and EMA?
  4. Is there any specific requirement for choice of originator product?
  5. What are the additional data required if the originator is not present in the country?
  6. Is there any specific clinical trial requirement (Choice of originator product, inclusion of local population etc)?
  7. Are there any specific requirements for raw materials like APIMF, excipients, packaging material etc?
  8. Is there any requirement of in-country QC release, testing or sample?
  9. Is there any requirement of separate GMP inspection?
  10. Are there any legislative timelines for registration of products?
  11. What are the fees for registration?

Conduct similar exercise for other categories like follow on vaccines, in vitro diagnostics.

Stage 3

In this stage, all guidance documents identified in stage 2 will be reviewed. Any critical guidance, which is not available in English language will have to be translated. For some guidance documents, a summary of key points can be provided instead of translating the whole guidance.

Outputs

Stage 1

Classification of the countries based on their capabilities on assessment of generic medicines.

Stage 2

Comprehensive report on the Group 1 and Group 2 countries to cover the questions enumerated in the earlier section. Any critical information with respect to any typical local requirement (other than those covered in the questions) needs to be highlighted.

References for the information, including links to websites, documents and transcripts of interviews conducted with local agents/ authorities (if any) will have to be appended to the report.

Stage 3

English translation/regulatory summary of the selected guidance to be provided.

Project Timelines

  • Last date to receive quotes: 15th Nov 2021
  • Kick-off meeting: By 3rd Dec 2021
  • Project Start date: By 6th Dec 2021
  • Draft submission: By 6th June 2022
  • Project End date: By 6th July 2022

Submission of Proposal:

The proposal should contain the following:

  • Profile of the consultant, including details about experience in similar projects
  • Methodology and work plan for the project, including a tentative schedule
  • Proposed quote for the proposal

All proposals should be submitted by email to Aditi Das, Business Development Manager, Technical and Regulatory at adas@medicinespatentpool.org with the subject RFP: MPP Regulatory Project. Please feel free to write to us in case any additional information or clarification is required.

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