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CTD Conversion

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.

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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

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Medicines Registration

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.

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Submissions Publishing

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.

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Food and Food Supplements

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  2. Food and Food Supplements
  • Navigating Food and Dietary Supplement Regulations in Nigeria

    November 23, 2023
    Food and Food Supplements
    Navigating Food and Dietary Supplement Regulations in Nigeria

    Businesses entering the food and dietary supplement market in Nigeria must be well-informed about the Regulatory environment in the country. With growing awareness of health and wellness among people, the demand for food and dietary supplements continues to grow globally. Let us now explore the key regulations governing food and dietary supplements, specifically in the Nigerian context, which can help you navigate the Regulatory framework in a smooth and effective manner.

    • Read more about Navigating Food and Dietary Supplement Regulations in Nigeria
  • Launching Food and Dietary Supplements in Japan: Navigating the Regulatory Landscape

    November 06, 2023
    Food and Food Supplements
    Launching Food and Dietary Supplements in Japan: Navigating the Regulatory Landscape

    Japan’s food and dietary supplement market holds great appeal, drawing health-conscious consumers who search for high-quality products. However, you need to navigate a strict Regulatory environment to enter this thriving market. In this blog, we shall explore the primary considerations for manufacturers planning to launch their food and dietary supplements in Japan, focussing on key areas such as Japan’s food import regulations, dietary supplement registration, and compliance with local laws and standards.

    • Read more about Launching Food and Dietary Supplements in Japan: Navigating the Regulatory Landscape
  • Demystifying EU’s Labeling Requirements for Food and Dietary Supplements

    November 06, 2023
    Food and Food Supplements
    Demystifying EU’s Labeling Requirements for Food and Dietary Supplements

    When it comes to labeling requirements for food and dietary supplements in the European Union (EU), you must pay close attention to detail. The EU has established strict regulations to ensure that consumers receive accurate and transparent information on the products they consume. In this blog, we shall delve into the essential aspects of the EU’s labeling requirements for food and dietary supplements, including the rules and regulations that govern the product claims and information.

    • Read more about Demystifying EU’s Labeling Requirements for Food and Dietary Supplements
  • The Mystery Behind FDA's Restriction on Nicotinamide Mononucleotide (NMN) Dietary Supplements

    October 31, 2023
    Food and Food Supplements
    The Mystery Behind FDA's Restriction on Nicotinamide Mononucleotide (NMN) Dietary Supplements

    Nicotinamide Mononucleotide (NMN) has been making waves in the world of dietary supplements. Touted as a potential fountain of youth and an elixir for longevity, NMN supplements have gained popularity among health enthusiasts. However, there's a catch: the Food and Drug Administration (FDA) has imposed restrictions on NMN dietary supplements, including FDA-approved food supplements. But why?

    • Read more about The Mystery Behind FDA's Restriction on Nicotinamide Mononucleotide (NMN) Dietary Supplements
  • The Controversy over Aspartame: The Critical Role of Regulatory Affairs in Ensuring the Safety of Food Additives

    October 12, 2023
    Food and Food Supplements
    The Controversy over Aspartame: The Critical Role of Regulatory Affairs in Ensuring the Safety of Food Additives

    Recently, the International Agency for Research on Cancer (IARC), the World Health Organization (WHO), and the Joint Expert Committee on Food Additives (JECFA) of the Food and Agricultural Organization (FAO) released assessments on the non-sugar sweetener, Aspartame. These assessments have sparked a contentious debate on the safety of Aspartame, particularly on its potential carcinogenic effects.

    • Read more about The Controversy over Aspartame: The Critical Role of Regulatory Affairs in Ensuring the Safety of Food Additives
  • Navigating Mercosur Food Regulations: Updates and Food Regulatory Services

    October 12, 2023
    Food and Food Supplements
    Navigating Mercosur Food Regulations: Updates and Food Regulatory Services

    Today, in an increasingly globalized world, the international trade of food and dietary supplements is subject to a complex web of regulations and standards. The Southern Common Market, abbreviated in Spanish as Mercosur, is a South American trade bloc comprising Argentina, Brazil, Paraguay, Uruguay, and Venezuela (whose membership has been suspended since 2016). Mercosur plays a vital role in shaping the regulations and standards for food and dietary supplements in the South American region.

    • Read more about Navigating Mercosur Food Regulations: Updates and Food Regulatory Services
  • Food and Dietary Supplement Trends and Regulations in the EU and UK Markets

    September 28, 2023
    Food and Food Supplements
    Regulatory Affairs
    Food and Dietary Supplement Trends and Regulations in the EU and UK Markets

    Food and beverage manufacturers in the European Union (EU) keep a close eye on the Regulatory landscape, and it is evident that various areas are garnering the regulators’ attention, from High-Fat, Sugar, and Salt (HFSS) laws to novel food regulations. This blog explores how these regulations impact food and food supplement manufacturers in the United Kingdom (UK) and Europe’s dietary supplement market; it also looks at the trends predicted for the industry.

    • Read more about Food and Dietary Supplement Trends and Regulations in the EU and UK Markets
  • Cultivated Meat: A Sustainable Alternative to Traditional Meat

    August 25, 2023
    Food and Food Supplements
    Cultivated Meat: A Sustainable Alternative to Traditional Meat

    What is Cultivated Meat?

    Cultivated meat, also known as cell-based or lab-grown meat, is produced by growing animal muscle tissue from cells in a bioreactor rather than from traditional animal agriculture. It aims at replicating the taste, texture, and nutritional composition of conventional meat while eliminating the need for raising and slaughtering animals. The concept of cultivated meat has been in the process of being developed for several decades, with significant advancements in stem cell biology and tissue engineering contributing to its current feasibility.

    • Read more about Cultivated Meat: A Sustainable Alternative to Traditional Meat
  • BPOM, Indonesia Regulates Microorganism Content Standards In Fermented Processed Foods

    August 09, 2023
    Food and Food Supplements
    Regulatory Affairs
    BPOM, Indonesia Regulates Microorganism Content Standards  In Fermented Processed Foods

    Indonesia has taken a step ahead in regulating processed foods and beverages. A set of guidelines or biotic regulations has been rolled out by the Badan Pengawas Obat dan Makanan (BPOM), or the Agency for Food and Drug Control/Indonesian Food and Drug Authority. The new set of regulations will not only govern the presence of microorganisms in general processed food and beverages like yogurt and kombucha, but they will also apply to probiotics.

    • Read more about BPOM, Indonesia Regulates Microorganism Content Standards In Fermented Processed Foods
  • South Korea Approves the First Physically Recycled PET Containers for Food and Beverages

    August 09, 2023
    Food and Food Supplements
    Regulatory Affairs
    Health Authority Updates
    South Korea Approves the First Physically Recycled PET Containers for Food and Beverages

    South Korea has taken a step towards carbon neutrality and has approved the first ever physically recycled Polyethylene Terephthalate (PET) containers for food and beverages.

    The new policy, applicable from January 17, 2023, only includes PET containers that have undergone a physical or mechanical recycling process and have not been subject to a chemical recycling process. As per the Promotion of Saving and Recycling of Resources Act (Recycling Act), the South Korean Ministry of Environment (MoE) has graded the packing material into the following four (04) categories:

    • Read more about South Korea Approves the First Physically Recycled PET Containers for Food and Beverages

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Publishing and Submissions
Regulatory Labeling

Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.

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Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.

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The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.

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