Freyr is supporting global Top 5 and Fortune Pharma/Biotechnology/Consumer and Medical devices companies with end-to-end strategic Regulatory services for their strategic Regulatory needs across new emerging markets like Africa including the South Africa, Sub Sahara and North Africa regions.
End-to-End Regulatory Services - Africa Markets
- Dossier Preparations, Review, Compilation and Submission of new Marketing Authorization Applications including supporting data
- CTD Conversion:
- Gap Analysis between the old format and new ZA CTD (Common Technical Document for South Africa) format which is mandatory as per the South African Health Products Regulatory Authority (SAHPRA) [formerly known as MCC]
- Dossier harmonization and Master Dossier Preparation based on CTD format and enabling companies to address the need for reusability of the dossiers for other markets in Africa outside South Africa (saving time for multiple country specific applications)
- Life Cycle Management (Variations/Amendments Preparations and Submissions)
- Compilation and Review of Package Inserts, Patient information leaflets and Labels
- Regulatory Submission & Publishing Services including eCTD Compilation
- Regulatory Labeling & Artwork Services
- Regulatory Market Intelligence and submission strategy for Sub-Sahara and North Africa regions
- GMP Support:
- Audits and inspections (internal and external)
- Quality manuals
- Standard Operating Procedures
- Product Quality review services
Africa Countries and Sub Sahara Regions Covered
- South Africa
Drugs Registration Services
Freyr Regulatory Affairs Consulting team consults and supports the sponsor applicants in the following areas of:
- Submission of all market authorization applications and supporting data to the SAHPRA in English (British)
Applications can include New chemical entity applications
- Multi source/generic applications and innovator product line extension applications
- Innovator line extension applications and Biological medicines
- Submission of Site Master File (SMF) in accordance with the SMF guideline
- Support the applicant in expedited review request to the Ministry of Health for the attention of the Registrar of Medicines
- Dossier compilation for medicines registration including updates, lifecycle management
- Compilation and review of package inserts, patient information leaflets and labels
Medicines to be used in South Africa for both public and private sectors shall be duly registered with the national regulatory authority, the Medicines Control Council’s (MCC) in accordance with the provisions and requirements of the Medicines and Related Substances Control Act No. 101 of 1965 and the Regulations and Guidelines published in terms thereof.
A written notification from the Minister to the effect that the medicine is considered essential to national health; an expert report (which is not more than 2 (two) years old; a package insert (where the product has been approved) and a summary basis for the registration (SBRA) should be submitted with application.
The Registrar shall notify the applicant within 30 days of the date of receipt of the application and the Council shall, within 9 months make a decision with regard to the application.
The abbreviated medicine review process is based mainly on the expert reports of the pharmaco toxicological and clinical data.
Applications for Abbreviated Medicine Review Process (AMRP) can only be accepted if the product has been approved by the said authorities within the last three years of the license in the licensing country.
Freyr Good Manufacturing Practice Services
Freyr provides guidance to Sponsors in cGMP matters and related:
- Audits and inspections (internal and external)
- Site master files
- Quality manuals
- Standard operating procedures
Good Manufacturing Practice
Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards.
- Regular periodic or rolling quality reviews of all registered medicinal products, including export only products are conducted.
- The Manufacturer and Holder of Certificate of Registration, where different, should evaluate the results of the review and an assessment should be made of whether corrective and preventative action or any revalidation should be undertaken.
Medicines Control Council’s (MCC) general policy is that the standard to be used to assess compliance with current Good Manufacturing Practice (cGMP), is the South African Guide to Good Manufacturing Practice (SA guide to GMP).
- Under Section 22C of the Act, all South African manufacturers should be licensed
- The Act requires that overseas manufacturers of medicine supplied to South Africa should comply with the same or equivalent manufacturing standards as expected of South African manufacturers
- When acceptable evidence of GMP compliance is not available, overseas manufacturers are inspected by the GMP Inspectorate before registration of the medicine is approved
Freyr CTD Conversion Services
Freyr provides the following services in supporting customers to meet the CTD mandate.
- Gap analysis between the old format and new CTD format
- Dossier harmonization and master dossier preparation based on CTD in enabling companies to address the need for reusability of the dossiers for other markets in and outside South Africa
- Provide a cost effective phased approach in meeting CTD mandate based on the number of product registrations and product registration priorities
In June 2010, The Medicines Control Council (MCC) announced the intention to implement the South African Common Technical Document (ZA CTD) format which will replace the current MRF1 and any applications still in MBR1 format.
From June 2011, submissions in ZA CTD format are mandatory (excluding veterinary medicines).
Freyr is currently working with many Global Pharmaceutical and Consumer Health Care companies in supporting them in planning and executing the CTD conversion requirement for the existing and new product registrations in South Africa enabling them to meet the MCC mandate. For some of these global companies CTD conversion is a time consuming and a huge responsibility that needs careful planning and execution given their growing product portfolio in the African market.
Freyr Regulatory Operations Services
Freyr supports Market Authorization holders to manage their product registration data, Health Authority (HA) commitments data, post approval safety and manufacturing change communication data including the current Regulatory status of their products outside South Africa to meet the compliance and reporting needs of the SAHPRA.
In June 2010, The Medicines Control Council (MCC) announced the intention to implement the South African common technical document (ZA CTD) format which will replace the current MRF1 and any applications still in MBR1 format. From June 2011, submissions in ZA CTD format are mandatory (excluding veterinary medicines).
With the need for converting old format submissions to CTD format comes the opportunity for Market Authorization Holders (MAH) to plan and be ready for electronic submissions. Freyr can compile submissions in eCTD format and print in paper format as required by the current MCC requirement. This allows the MAHs to be prepared for future eCTD requirements from MCC and enables efficient electronic submission dossier management.
Registrations and Submissions Information Management
Module 1 (Administrative 1.10 Foreign Regulatory Status) requirement from Medicines Control Council’s (MCC) requires the applicant to provide a list of countries in which an application for the same product is being applied for in South Africa has been submitted, dates of submission (if available). This should detail approvals (with indications). Applicants must declare whether a marketing application for the medicine has been rejected in the countries listed under 1.10.1 prior to submission of the application in South Africa. If the medicine has been rejected, repeatedly deferred or withdrawn, then the MCC must be informed and the reasons supplied.
If no application has been submitted for registration in the country of origin, include a statement to provide the reason for this decision. It should be noted that aforementioned information is required to be provided in dossier however, it does not mean that this will help to speed up the review process.