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.
South America
East Europe
Europe
North Africa & Middle East
Southern Africa
APAC
Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards.
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).
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.
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.
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.
The United States stands as an industry hub for the Life Sciences sector. With continuous innovation and growth, the country showcases significant potential for foreign medicinal products’ and medical devices manufacturers. As a well-established regulated market, the U.S. obliges manufacturers to adhere to the United Sates Food and Drug Administration’s (US FDA) stringent guidelines for compliant market entry.
Pharmaceutical market in the United States of America (USA) is considered the best for its established Regulatory framework. The US Food and Drug Administration (US FDA) regulates the manufacture, import, distribution and marketing of pharma products in the country. The term pharma in the USA overarches numerous products and each of them possess a different approach to obtain market authorization.
United States of America (USA) is the largest market for dietary supplements across the globe. They are regulated by United States Food and Drug Administration (US FDA). With an evolved Regulatory regime, FDA does not review and approve dietary supplements based on their safety and efficacy before approval but rather evaluates them through adverse event monitoring and research. These products require a notification to FDA, 75 days prior to their marketing. FDA is also responsible for regulation of ingredients of the dietary supplements.