REGISTER OR PUBLISH? REFLECTION PAPER ABOUT TWO

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LETTER TO EDITOR
REGISTER OR PUBLISH? REFLECTION PAPER ABOUT TWO IMPORTANT ISSUES DURING THE
DEVELOPMENT OF NEW DRUGS. CUBAN CONSIDERATIONS.
(¿Registrar o Publicar? Manuscrito de reflexión acerca de dos importantes aspectos durante el
desarrollo de nuevos fármacos)
Diadelis Remírez Figueredo, Caridad Hernández y Deybis Orta.
Centre of State Quality Control of Drugs and Medical Devices.
ABSTRACT
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The Regulatory Agencies are the responsible for controlling quality, safety and efficacy of drugs. One of the main objectives of the Drugs
Regulatory Agency is to authorize the commercialization of pharmaceutical products (Register). It means to put into the market the drugs with
the required quality, safety and efficacy. This work focuses the attention, about the importance of registering and publishing, the differences
between both processes. It is described the main requirements for registration in Cuba and How to use the useful information of papers for
registering. New Cuban products which have been registered with very high impact of papers will be included in this work. How deep should the
papers be and how simple or complex should the registration be? Both of these aspects will be clarified in order to get better registration with
papers included.
Keywords: Register, Publishing, Cuba, Requirements.
Rev. Farmacol. Chile (2015) 8(3) 7-9
Received 28-06-2015; Revised 20-11-2015; Accepted 24-11-2015
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1) BACKGROUND
Drug approval is the goal of the long process of drug
development. Once preclinical and clinical trial data have
been collected, a New Drug Application must be submitted
to the regulatory authority for approval. Registration of
drugs is an essential element in drug regulation. All drugs
that are marketed, distributed and used in Cuba should be
registered by the national drug regulatory authority.
Every drug, before receiving approval for marketing must
undergo rigorous scientific testing and scrutiny to ensure
that it is safe and effective for its intended use. Drug
development starts with lab assays, in vivo animal studies
in
order
to
evaluate
the
pharmacodynamic,
pharmacokinetic and potential toxicities of a product. Once
theses studies are complete, the sponsor of a drug submits
the authorization for starting the clinical trials. During the
clinical trials, products typically undergo three phases of
studies: Phase I, Phase II and Phase III, which represent the
giving of the new drug to increasing numbers of patients in
an effort to characterize safety and efficacy. Phase I consist
of the initial administration of the product, the safety and
tolerability is evaluated.
During the phase 2 the therapeutic effect is explored and
in the phase 3 the efficacy is confirmed. All these phases
should be approved by Regulatory Agency, once the clinical
trials are completed, the results are tabulated and
analysed by the sponsor and then submitted as a New Drug
Application (NDA) to the Regulatory Agency (RA). The NDA
then presents to RA reviewers the entire history of the
development of a drug product. It is the job of any
regulatory agency to review the data and determine
whether the product meets the criteria for marketing.
How to assess?, Who should assess?
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Correspondence to: Dra. Diadelis Remírez Figueredo. Centre of State Quality Control of Drugs and Medical Devices. Address: Calle 5ta A #6020 e/ 60 y 62. Miramar,
Playa. Código Postal 11300. La Habana, Cuba. Teléfono: +53-7 216 4100, Email: [email protected]
Rev. Farmacol. Chile (2015) 8(3)
7
Marketing authorization is a system for the pharmaceutical
products for pre-trading for ensuring all the required
standards for quality safety and efficacy settled by the
Drug Regulatory Agency. A single marketing application
should be sufficient to ensure product safety and
effectiveness as well as to ensure consistent and
appropriate post- marketing regulation.
Cuba is a small country with limited resources but it has an
almost 100 percent literacy rate. Cuba has generated
scientific results with high technology, such as: the
production of novel products (monoclonal antibodies,
therapeutic vaccines, biological products etc), these
advances have been the result of integrated researchproduction-trading organisations, the help of the state,
social ownership, export orientation and the
comprehensive integration of the Cuban biotechnology
multi-institutional system.
2) INFORMATION REQUIRED FOR REGISTRATION OF NEW
PRODUCTS IN CUBA.
Administrative Information
Chemical pharmaceutical and biological information.
Preclinical Information
Clinical Information
Why publish the data?
•
In order to provide the information about the
results the broader scientific community.
•
Evaluation of the results by international and/or
national experts.
•
To avoid the duplicity of results.
•
To get prestigious or position in a specific field at
national or international level.
Types of papers.
•
Short communications
•
Scientific articles
•
Reviews
Register or to publish?
How many articles make up the register?
Papers are written according to requirements of the
journal, and it can be as in depth the author wish.
Registration is according the requirement of regulatory
agency and author should provide enough information
required in order to convince the reviewers of the novelty
of the product submitted. In this sense the registration can
include papers published or not, the published papers in
international journal denote that the results have been
evaluated by international experts. These papers are
considered as reliable evidence for the results presented in
the register.
Rev. Farmacol. Chile (2015) 8(3)
3) REQUIREMENTS IN CUBA.
Chemical-Pharmaceutical Issues:
Qualitative and quantitative composition stability,
concentration of active principles, characterization of the
components, risk excipients. In this issue is not necessary
to publish all the content.
Non clinical assessment It is included all the toxicology
studies (mutagenesis, reproductive, carcinogenesis studies)
and investigation of the mechanism of action of the new
product. In these aspects new techniques related with
alternative and molecular toxicology, and pharmacology as
well could be carried out as well as these results could be
published.
Clinical assessment from phase I-III should be carried out
before the registering, the results could be published.
Main Cuban products registered with huge international
papers.
•
Interferon
•
Vaccine hepatitis B
•
Ateromixol
•
Monoclonal antibodies
•
Vaccine Haemophylus influenzae
•
Heberprot
Pharmacological mechanisms examined in non-clinical
trials would be useful for selection of the appropriate endpoint in the clinical trials. For safety assessment,
International Conference of Harmonization (ICH) Guideline
on Safety Pharmacology Studies was officially notified.
According to pharmacological data on safety, clinical
investigators can better design clinical trials to prevent
patients from suffering serious adverse events. To
development new pharmaceuticals, continuous progress
on pharmacological research will be indispensable. Further
discussion among all interested parties such as
pharmacological researchers, medical doctors, companies,
and regulatory sites will be necessary and useful to
develop more appropriate approaches in the
pharmaceutical development process.
With the current trends of globalization, where crossborder trade for pharmaceutical products increases in
many parts of the world, the need for effective drug
regulation at national and international levels becomes
more important than ever.
4) CONCLUSION
The most important is to know that papers can be as short
or longer as the author decides, but the application for
registering should fulfil the requirements settled for each
country.
8
RESUMEN
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Las agencias reguladoras son los organismos responsables de controlar la calidad, seguridad y eficacia de los medicamentos. Uno de los objetivos
principales de estas agencias es la autorización de comercialización de los productos farmacéuticos (Registro). Esto significa colocar en el
mercado medicamentos con la calidad seguridad y eficacia requerida. Este trabajo enfoca la atención acerca de la importancia del registro y de
las publicaciones científicas y las diferencias entre ambos procesos. Se describen los principales requisitos para el registro en Cuba y como usar la
información de las publicaciones para el registro. Nuevos productos cubanos los cuales han sido registrados con publicaciones de alto factor de
impacto serán descritos, además de la profundidad de las publicaciones y lo simple o complejo de los registros. Ambos aspectos serán aclarados
con el objetivo de obtener mejores registros con publicaciones incluidas.
Palabras Claves: Registro, publicación, Cuba, Requisitos
Rev. Farmacol. Chile (2015) 8(3) 7-9
Recibido 28-06-2015; Revisado 20-11-2015; Aceptado 24-11-2015
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Rev. Farmacol. Chile (2015) 8(3)
9
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