Welcome to the February issue of FREYRFOREWORD!
A monthly round-up of the latest happenings and updates from Freyr.
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.
North Africa & Middle East
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.
A monthly round-up of the latest happenings and updates from Freyr.
|FREYR LAUNCHES SPECIALIZED MEDICAL WRITING SERVICES
Freyr now offers strategic medical writing services across a spectrum of domains to the global biopharmaceutical industry. Freyr also provides a full range of writing services in medical writing that include writing scientific documents of diverse nature covering all regulatory and research-related documents, disease or drug-related educational and promotional literature, publication articles like journal manuscripts and abstracts, content for healthcare websites, health-related magazines or news articles.
Freyr also offers end-to-end medical writing services to clients in pharmaceutical and medical device industries.
Freyr’s services include:
• Writing/editing of regulatory submission documents
Freyr is uniquely positioned to provide best-in-class services based on similar successful partnership experiences, therapeutic area expertise, and delivery rigor. Freyr’s medical writing associates have extensive experience in medical writing & publishing for more than 120 studies across a broad range of therapeutic areas.
| FREYR INTRODUCES MEDICAL DEVICES REGULATORY SERVICES
Freyr announced the launch of new medical devices regulatory services designed to provide a focused, market-driven approach to ensure compliance with global regulatory requirements. The new service offers an effective regulatory strategy to medical device companies to gain competitive edge in meeting the regulatory requirements.
In addition, Freyr provides end-to-end services starting from device classification to market approval which includes appointing legal representative and offering guidance in attaining certifications like QMS etc.
Freyr will assist in navigating across any regulatory issues and offers a path to approval across multiple jurisdictions through implementations of a strategic plan in registering the device for different agencies which makes the approval process easier. Freyr’s specialized services will enable the device companies efficiently address the increased scrutiny from national regulatory agencies while minimizing downstream risks.
|It is tough for Pharma companies to be cognizant of all existing global regulatory requirements owing to the ever changing worldwide regulations and legislations. New procedures are always being developed and adopted by regulatory authorities worldwide due to the international harmonization process.|
|PHARMACEUTICAL COMPANIES AND REGULATORY INTELLIGENCE
In the current regulatory climate, most of the Pharmaceutical companies are struggling to maintain research and development (R&D) productivity. Pharma companies are keen to explore new drug development models which can cut development costs, accelerate timelines and still maintain quality and compliance.The swift turn to modernize their development operations is partly to do away with obsolete models of development in particular, in-house technology solutions that will in turn offset slowing growth rates to achieve bottom line results.
REGULATORY INTELLIGENCE IN EMERGING MARKETS
Emerging markets in Asia Pacific, Latin America and Eastern Europe are increasingly important locations for drug development as sponsors pursue multinational programs to gain access to appropriate patient populations. Emerging markets which have been termed as the promised land, account a third of the global pharmaceutical market by 2016. The markets are a hot bed of huge populations, increasing prosperity and improving longevity, another positive aspect.
There are three main clusters the BRICMT economies (those of Brazil, Russia, India, China, Mexico and Turkey), second-tier countries such as those of Southeast Asia; and finally Africa. Companies must balance their global competences with tailored approaches for regulatory intelligence functions for these emerging markets. Regulatory intelligence functions must be structured to define market-tailored and effective business strategies for each market segment which will allow companies to avoid losses in terms of revenue and commercial viability.
RI GROUPS: PAIN POINTS
In the 2014 survey about a centralized RI program, customers place high value but low satisfaction on the products of the RI group. The central RI program is usually located at the company headquarters and is managed by a relatively small staff with additional staff employed for a major market alone
All companies perform regulatory intelligence to some extent and more companies are establishing dedicated intelligence groups. Regulatory intelligence scope does vary in form of active analysis and interpretation, however it does not equate to regulatory information. Furthermore regulatory intelligence is imperative along with allocation of key tasks to ensure compliance, future awareness and adequate resourcing. Benefits of having the correct regulatory information will enable to design and implement a good regulatory strategy which can lead to reduced time to market both via accelerated development and smoother registration assessment, reduced costs, increased compliance and ultimately optimization of return on investment.
|As an organization, we at Freyr, have always placed the highest value on our business associations and partnerships. It has been our guiding principle to identify newer opportunities and create exceptional engagement excellence for our clients that transform into long-term relationships. As always, it is a great pleasure to announce the New Wins.|
|GLOBAL REGULATORY INTELLIGENCE SERVICES FOR $17+ bn Top-50 CONSUMER PRODUCTS COMPANY
|STRATEGIC REGULATORY SERVICE for $600+ Mn GLOBAL SOUTH KOREAN PHARMA COMPANY
|Why a Company Core Data Sheet (CCDS) is required and what is its significance for the marketing authorization holders (MAH).
Creation, maintenance and updating the CCDS costs money to the MAH and requires lot of time and effort. Keeping the CCDS up to date is a continuous process, and as soon as significant new information is noted it should be reviewed for updating the CCDS.
|MARKETING AUTHORIZATION HOLDERS: APPROVALS
The MAH has to submit the labels to the local competent authority and get it approved in the countries where they want to do business. After approval, this will become the official label for that country. The CCDS as per the ICH E2C (R1) is defined as “It is a common practice for MAHs to prepare their own “Company Core Data Sheet” (CCDS) which covers material relating to safety, indications, dosing, pharmacology, and other information concerning the product.
A practical option for the purpose of periodic reporting is for each MAH to use, as a reference, the safety information contained within its central document (CCDS), which will be referred to as “Company Core Safety Information” (CCSI).” The local label (SmPC or USPI) is the official label for a product in that country and is approved by its local health authority.
This local label can be a prescriber’s information, patient information or the label on the carton. Local health authority reviews and approves the label in accordance with its rules, regulations and guidelines. Hence, the final local label might have difference with the proposed label submitted by the MAH. Hence, the local label might deviate from the company position on a product.
HEALTH AUTHORITIES: LABELING TEMPLATE
Health authorities have their own template for the labels, which is different from others. For example, European Union Summary of Product Characteristics (EU SmPC) template has a section on “driving and using machines” and even if there is no relevant information available for this section the local label should contain this section explaining the same.
However, in the USPI or various other country labels this section is not a part of the template and the information related to driving and using machines would only be included in local label if there is enough evidence to support any impact (actual or potential) on the ability to do work which require alertness like driving and using machines, in that case this information can be added to the appropriate section e.g. the warnings or precautions section.
|Hence, it is important for the MAH, especially when doing business in different countries, to have the labeling document which can be used as a reference document globally. This leads to a question that what should be the template of the CCDS, should it follow any local template e.g. EU SmPC or the USPI or should it use a hybrid template which can cover minimum safety information and leave anything specific to local templates.
GLOBAL HARMONIZED LABELING
It is more important for the companies doing business in multiple countries and regions as
It should be kept in mind while developing the hybrid template that it should contain all those sections which are related to safe use of the product and allows inclusion of the minimum safety information in the CCDS. However, the local label can still have any country specific information and any information mandated by the local HA.
CCDS: AN IMPORTANT GUIDE FOR THE PRODUCT PROMOTIONAL CONTENT
CCDS is not only used to create the harmonized labeling or for pharmacovigilance but it is also important guide for the product promotional content. It can act as a tool to control the promotional content centrally. To serve all the purposes discussed above the CCDS for any product need to be updated on the regular basis, and as soon as any new safety information comes to knowledge.
The new information should be added to the CCDS only if it has enough scientific evidences to support the inclusion and should not be driven or influenced by any business interest of the company.
This should be discussed in detail as the rationale for the CCDS update and should be authored by the well qualified experts. MAH should also ensure that their promotional material is in line with the labeling.
The scope of project is to generate the regulatory and market intelligence data for Pharmaceuticals for seven countries in Sub Saharan Africa region identified by the client – Kenya, Ghana, Tanzania, Zambia, Angola, Nigeria and South Africa
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