What is an RTA?
In the context of medical device Regulatory Affairs, a Refusal to Accept (RTA) is a request from the US FDA for additional information or clarification on information submitted in a 510(k) application.
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.
In the context of medical device Regulatory Affairs, a Refusal to Accept (RTA) is a request from the US FDA for additional information or clarification on information submitted in a 510(k) application.
The development of In-Vitro Diagnostic (IVD) devices is a classic example in the healthcare sector, where modern technology has enabled healthcare professionals to improve treatment regimes for serious life-threatening health conditions. While Regulatory agencies worldwide are working towards harmonized regulations to market IVDs, China’s NMPA has led to stringent guidelines for the regulation of IVDs in China market.
The analytical performance is described in European Union In Vitro Diagnostic Regulations (EU IVDR) 2017/746 as “the ability of the device to correctly detect or measure a particular analyte.” The analytical performance of any IVD/s is demonstrated based on the analytical performance studies, which are then documented as Analytical Performance Report (APR).
A Scientific Validity Report (SVR) is a part of the Performance Evaluation Report (PER) under the European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 that documents the scientific validation of the IVDs. The SVR supports the device's conformity assessment and for the same one must consider any relevant published literature and standards.
The European Union Medical Device Regulation (EU MDR) 2017/745 is a regulation that sets out the requirements for medical devices in the EU. The regulation provides the evaluation of medical devices prior to marketing, and one of the key requirements is the need for clinical investigations.
As stated in the European Union Medical Devices Regulations (EU MDR) 2017/745, clinical investigation, is “any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device” The entire purpose of clinical investigations is to demonstrate that medical devices are safe and effective when used for their intended purpose.
In the early years of the next century, the Japanese population is expected to become the oldest in the world. The Japanese government's concentration on post-World War II economic expansion meant that the government fully woke up to the financial implications of having a large elderly population when the oil prices skyrocketed in the 70s, highlighting Japan's economic dependency on global markets.
Breast milk is the gold standard for infant feeding and nutrition. Lysozyme and Human Milk Oligosaccharides (HMOs), which specifically promote the colonization of infant-type HRB, are among the bifidogenic components of breast milk.
Electronic Product Information (ePI) refers to the electronic version of the Patient Information Leaflet (PIL) that is provided with medicines. The ePI contains important information about the medicine, such as its active ingredients, indications, contraindications, dosing instructions, side effects, precautions, and storage conditions.
Electronic submissions have taken the life science industry's Regulatory space by storm. Majority of the Regulatory submissions are now made using the eCTD format globally. The benefits of eCTD are undeniable - faster, more efficient, and standardized. But transitioning from non-eCTD electronic Submission (NeeS) to eCTD isn't always a cakewalk.