Welcome to the September 2015 issue of FREYRFOREWORD!
A monthly round-up of the latest happenings and updates from Freyr.
From a global perspective, the commercial significance of markets is increasing and it is
The International Conference on Harmonisation’s (ICH) Common Technical Document (CTD) can serve as a resource for most local MA applications. In addition, a large amount of mandatory and highly country-specific documentation (related to infrastructure, legal documents, stability studies, labeling, etc.) requires strategic planning and allocation for timely local approvals. Organizations can face challenges owing to identification of actual requirements due to frequent changes in regulations, unclear expectations, etc.
The pharmaceutical industry will benefit if they have clear visibility of the country-specific requirements and health authorities (HAs) expectations in LATAM and also improve their planning activities when submitting the global MA applications. This will also help in managing internal expectations and offer patients in the region faster access to therapies.
Each LATAM HA has strengthened its health legislation which is a continuous evolving process; however variation in drug registration processes causes time-consuming and costly obstacles for companies. The article tries to focus on MAs for prescription drugs (including biologics/biotech). Latin American countries must harmonize their basic vocabulary on pharmaceutical products and reach agreement on the technical procedures needed to ensure the quality of multisource products.
LATAM PHARMACEUTICAL MARKET
Adaptation and Growth
More than 20 countries and territories including Aruba, the Bahamas, Cuba, the Dominican Republic, Haiti, Jamaica and Trinidad and Tobago. The first language of most Latin Americans is Spanish, except Brazil where Portuguese is spoken. There is a marked diversity of influences and also the politics to a certain extent contribute to the HAs’ idiosyncrasies.
Pharmaceutical Trends: Growing Domain of Generics Market
There are also country specific challenges to pharmaceutical companies seeking market penetration in the region as there is no regional “CTD” application. Each MA application must be planned and executed as per requirements of each country’s HA. PAHO has recognized five national reference authorities from Argentina, Brazil, Colombia, Cuba and Mexico for the LATAM region.
In Argentina, the term “generic” is used indiscriminately causing confusion. The Minister of Health- Argentina announced an initiative through a resolution 326 and law 25.549 to promote the use of generic drugs, competition and to lower prices, resulting in increased accessibility. However national and provincial medical associations opposed the policy owing to ambiguity of the term “generic” and stated that none of the drugs sold as generic drugs in the country had proven bioequivalence as required by law. The government’s initiative was to explore if expensive branded originals could be replaced with similar drugs, which were offered in markets under branded and International Nonproprietary Names (INN). Medical associations thought that the quality of the similar drugs was questionable and hence opposed the policy.
Also drug companies opt for lengthy testing if they want to restrain competition while other drug companies who want to expedite availability of cheaper versions of drugs which is sufficient to guarantee efficacy and safety of drugs opt for limited testing. There is also confusion on classification of pharmaceutical products commonly used in Latin America as there is a lack of consensus on classifying these products, across pharmaceutical industry experts. In addition, pharmaceutical industry experts had different interpretations of the word bioequivalence. As of now LATAM countries are trying to reach agreement on the type of tests to be carried out ahead of approval of commercialization of multisource drugs.
Time Frame for Product Registration
In today’s uncompromising regulatory climate it is imperative for companies to produce accurate scientific, medical and regulatory documents. Regulatory writing- a discipline that evolves with new and updated regulations and guidelines. Medical writers are specialized in writing all kinds of high quality regulatory documents. It must be noted that a single medical writing document is the culmination of many hours of hard work by study teams, and is essential to creating high quality documents. Poorly written regulatory documents may lead to delays in regulatory approval, costing time and money for the sponsor.
It is important that all regulatory documents are presented in a clear and unbiased manner. Regulatory medical writers must adhere to stringent regulatory requirements while keeping in mind the needs, preferences and styles of sponsors/study teams. Regulatory medical writing plays a large role across the evidence generation continuum and also adds a lot of value in the production of clinical trial documentation.
The medical writers can aid in all steps right from protocol development to the submission process. In short regulatory medical writing is of key importance in developing and conveying the strategic message of the data and is an integral part of clinical research. A clinical development program is deemed successful if it has proper documentation of research plans and results.
Regulatory Medical Writing is an activity of writing / communicating clinical and scientific data. The process involves writing regulatory documents like protocol, Clinical Study Report (CSR) narratives, Safety Update Report, Investigator Brochure (IB), Investigational New Drug (IND), New Drug Application (NDA) submissions and other documents as per Common Technical Document (CTD) or eCTD that are submitted to regulatory authorities for approval. It also involves writing commercial documents like abstracts, manuscripts, posters, oral presentations for Congress/ Conferences/ International Meetings, educational slide sets and training modules for medical professionals
In the end, clients will prefer to work with a CRO that have medical writers who consistently produce high quality documents in the promised time frame. A quality document delivered a week late, does no good to the client. And the converse is also true - A document completed on time, but if it’s less than stellar, then the client may move their business elsewhere. With so many CROs out there, pharmaceutical companies have their pick of medical writers to work with, so the measured index of productivity is to consistently deliver quality documents in a systematic and timely fashion.
|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 of this quarter.|
|ECTD SERVICES FOR $15+BN GLOBAL PHARMA COMPANY
LABELING MANAGEMENT SERVICES FOR $2+BN, BIOTECHNOLOGY COMPANY
STRATEGIC REGULATORY SERVICES FOR EUROPE BASED HEALTHCARE COMPANY
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