drug and food regulation in Cuba

1. Food and Drug
Administration in Cuba
Mohammad Javad Rajabi
Kerman Medical University
December 2020
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2. CECMED
1. History and Overview
2. Drug And Biological Evaluation
3. Quality Management System
4. Evaluation For Registration
5. Surveillance
6. Inspections
7. National Control Laboratory
8. Clinical Trials Evaluation
Heading
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MINAL
1. Overview
2. Structure
3. Public policies
4. Service and Procedures

3. 3
CECMED
Center for State Control of Drugs, Equipment
and Medical Devices
Autoridad Reguladora de Medicamentos, Equipos y Dispositivos
Médicos de la República de Cuba

4. • Cuba has become a global leader in the South-South transfer of technology, helping low-
income countries develop their own domestic biotech capabilities
• BRICS: Brazil, Russian Federation, India, China and South Africa
• April 21, 1989
• Vice Ministry of Science and Technology of the Ministry of Public Health (MINSAP)
• centralize control actions on drugs and diagnostics tolls and develop them
• control functions established by the World Health Organization (WHO) for medicines
• Pharmacological Surveillance Center
1. History
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5. • The functions of CECMED were established in 1994 and as its roles
were identified the improvement of the legal and methodological basis
of control, the updating of requirements and evaluation of registration
requests, the authorization and control of clinical trials, the inspection of
current regulations , manufacturing inspection, production, distribution,
export and import licenses, quality evaluation and batch release of
biological products, control of blood banks, analytical and material
organization controls reference and regulation of quality, safety and
efficacy of products of natural origin; providing scientific information
and conducting post-marketing surveillance.
1. Overview
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6. • the CECMED declared as its objective that of “Planning, investigating,
regulating, organizing, directing and controlling activities aimed at
guaranteeing that all drugs and products for diagnostics destined for
research, medical assistance, the consumption of the population and
the export comply with the requirements established in the regulations,
standards and provisions in force in this area declared in the National
Pharmaceutical Policy Related to the State Control of the Quality of
Medicines and Diagnostics
• automation for the registration of drugs with the installation of the
“CUBDIS” system in 1989, There is currently a Statistical System for
the Control of Procedures developed in the country
1. Overview
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7. • The Department of Evaluation of Medicines and Biologicals is responsible for
controlling, establishing the health regulation of medicines, the evaluation of all
applications for health registration and all those that are related to this fundamental
activity
• This Department develops The activities associated with the sanitary registry and
Evaluation and approval of clinical trials performs as a drug regulatory authority.
2. Drug And Biological Evaluation
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8. • The Department has a qualified staff, graduated in different branches of knowledge and has pharmacists,
doctors, engineers, microbiologists, biochemists, who make possible the comprehensive evaluation of
authorization requests related to the sanitary registry of medicines for human use.
• It is structurally divided into the following sections:
- Drug Evaluation Section
- Biologics Evaluation Section
• The regulatory action of the Department is directed to drugs (generic or not); to disinfectants for hospital
use; to the products of natural and traditional medicine; to vaccines; allergenic extracts; vaccinations;
blood products and all biological products, regardless of the route used to obtain them.
• The Department of Evaluation of Medicines and Biologicals and the regulatory functions that are
inherent to it are part of the Quality Management System (QMS) of CECMED. All these processes are
duly documented through standard operating procedures (SOP) and work instructions. As an integral
part of the CECMED QMS, these processes are evaluated quarterly.
2. Drug And Biological Evaluation
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9. 3. Quality Management System
• The CECMED, in the search for a suitable system for the improvement of the
performance of its functions, it was proposed since 2000 to work towards the
implementation of its Quality Management System (QMS), a responsibility that
would be directed and coordinated by the Management Section of Quality, taking the
ISO 9001 standards as a reference. This implies the application of a set of
organizational and technical requirements fundamentally aimed at guaranteeing the
demand and compliance with the standards of a highly specialized service that
provides the speeding up of the corresponding procedures and traceability of its
processes in order to lay the foundations to achieve greater credibility in its
decisions, greater strength and stability of its functions and a systematization in
planning, the control and improvement of the quality of the processes, as well as
the elevation of the levels of efficiency and therefore customer satisfaction. According
to WHO / PAHO criteria, Quality Management systems are an indicator to be
considered to evaluate their qualification.
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10. 3. Quality Management System
• The processes that currently make up the QMS are:
• From top management: -Strategic Planning / -Knowledge Management / -
Measurement Analysis and Improvement.
• Of realization: -Reception and delivery / -Regulation / -Registration / -State Inspection
of Good Practices / -Release of lots / -Authorization of Clinical trials / -Analytical
control / -Post marketing surveillance
• Support: -Metrological Assurance / -Maintenance / -Material Resource Management / -
Computer Assurance
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11. 3. Quality Management System
• The processes in their performance are governed by documents prepared and
approved for the development of their activities and the maintenance of objective
evidence. These documents are part of the documentation system together with the
mandatory QMS documents, which are the following
1) document control system guarantees: records, related to quality are identified,
prepared, reviewed, approved, registered, distributed and updated in a
systematic way
2)The external documentation: pharmaceutical regulations and national and
international standards, pharmacopoeias and reference guides that are applicable to
drug control is part of the QMS documentation and is kept identified and updated
• 2007 National Certification Office of Cuba (ONN) and the Association for
Standardization and Certification of Spain (AENOR) and in 2008
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12. 4. Evaluation For Registration
1) Information On Drug And Biological Registries
The Sanitary Registry is the authorization issued by CECMED, to market a certain drug
for human use in the national territory. The evaluation process consists of the review of
all the information submitted by the applicant to verify satisfactory compliance with the
quality, safety and efficacy of a product, as well as the characteristics of its
manufacturer.
Like all processes that occur in the Department, the registration process is documented
through standard operating procedures (SOP) and work instructions that are applied
in the two Sections that make up the current work structure.
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13. 4. Evaluation For Registration
2) Information On Medical And Diagnostic Equipment Records
The purpose of evaluating the conformity of medical equipment and devices for the Health
Registry is to verify compliance with the essential requirements of quality, safety, efficacy
and effectiveness, through an objective analysis of the documentary evidence presented by the
manufacturer and the information collected for the computer or device being evaluated.
These evidences constitute the primary data to carry out the state evaluation for the sanitary
registry as an evaluative process with a scientific-technical nature.
The timely and accurate diagnosis, treatment, and monitoring of diseases requires effective and
safe diagnosticians, in accordance with the scientific and technological development achieved in
the different medical specialties. The Diagnosis Marketing Authorization (ACD) or Health
Registry is the procedure by which CECMED evaluates the safety and effectiveness of a
diagnostician with a view to its commercialization in the national territory. To do this, it verifies
that these products comply with the requirements established in current regulations, which are in
correspondence with their potential risk, so that the regulatory requirement is greater than those
that have a greater associated risk.
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14. 5. Inspections
• The State Inspection of Good Practices (IEBP) is the set of activities that plans, organizes and
executes the Center for the State Control of Medicines, Equipment and Medical Devices
(CECMED), with a view to checking whether active pharmaceutical ingredients, medicinal
Human use , raw materials for obtaining human blood derivatives and diagnostics are
produced, controlled, released, stored, distributed, imported and exported in accordance
with applicable and current Good Practices.
• The IEBP is carried out at state centers, corporations, firms and their dependencies that are
related to research - development, production, storage, distribution, import and export.
• For medical equipment and devices, regulatory audits are performed on manufacturers,
suppliers and importers of these technologies with the aim of verifying compliance with the
requirements for quality management systems and other regulatory requirements. Evaluation of a
manufacturer's quality management system determines whether the manufacturer has the ability
to consistently produce medical equipment and devices that meet essential requirements.
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15. 6. National Control Laboratory
• The National Control Laboratory (LNC) has the mission of “checking the quality of
medicines, natural products, biological products, reagents for in vitro diagnostics, medical
equipment and devices at the request of the Lot Release, Registry, State Inspection processes
Good Practices and Post-Marketing Surveillance; as well as providing analytical services to
external clients, in accordance with current standard operating procedures and previously
validated or verified analytical methods ”, so its main function is to verify compliance with the
quality specifications approved for the products subject to control and regulation.
• At the LNC there is a Quality Unit, made up of highly qualified technical personnel,
responsible for ensuring the technical competence of the laboratory, compliance with the
data integrity policy to obtain reliable results
• issuing recommendations for the approval of validation reports / verification of test
methods, among other activities in compliance with the requirements of Good Practices and
established in the following standards and guides: WHO Good Practice Guide for Quality
Control Laboratories for pharmaceutical products, Guide for Good WHO Pharmaceutical
Products Microbiological Laboratory Practices and General Requirements for the competence of
Testing and Calibration Laboratories.
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16. 7. Surveillance
• The CECMED is the main effector of the surveillance of the safety of medicines,
medical equipment and devices in the country, it is the institution to which all the
information is taxed for the taking of regulatory actions. The Pharmacovigilance (PV)
activity is developed by a Coordinating Unit, located in the Pharmacoepidemiology
Department, within the Directorate of Medicines and Medical Technologies of the
MINSAP and by a PV manager in each province of the country. For its operation, a PV
program is implemented for all health professionals and technicians, with a single
method of validation and identification of the risks associated with the drugs on the
market.
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17. 7. Surveillance
1. Pharmacovigilance
• Consultation of information on everything concerning pharmacovigilance with sections
dedicated to healthcare professionals, focal points for active surveillance, patients and
the pharmaceutical industry. It also has two distribution lists in which information on
safety, therapeutics, research and rational use of drugs is replicated. In addition,
consultancies are published on different topics related to this important activity.
2. Surveillance Of Medical Equipment And Devices
• Surveillance of medical devices allows the identification of risks, the investigation of
incidents and adverse events, as well as the timely disclosure of information related to
the use of products that are incorporated into medical care and that are distributed in the
country, for protect the health and safety of patients, users and the general
population, guaranteeing the essential requirements of safety, efficacy and effectiveness
once introduced into the National Health System.
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18. 8. Clinical Trials Evaluation
• in Cuba, CECMED is the competent authority in charge of evaluating and authorizing the
start of each of the clinical trials that are planned or proposed during the clinical
evaluation strategy in the development of a research product. As the Regulatory Authority
of the country we guarantee the safety, protection, rights and benefits of the subjects
included in any of the stages of the research in which they participate and taking into
account the Declaration of Helsinki.
• Likewise, it is guaranteed that each site where a clinical investigation is carried out is
accredited, as established by Good Clinical Practices (GCP) and the Clinical Trials
Inspections Program, regulations and technical standards in force.
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19. 19
MINAL
Ministry of the Food Industry of Cuba
Ministerio de la Industria Alimentaria de Cuba

20. 1. Overview
• The Ministry of the Food Industry of Cuba (MINAL) was created on March 2, 2009 as a
result of the extinction of the ministries of the Food Industry and the Fishing Industry
1) Propose to the Government the policies for the industrial production of food,
including the branch of beverages and liquors and that of fishing, and once approved,
exercise their direction and control.
2) Direct the use and preservation of fishing resources in the territorial sea, the exclusive
economic zone and inland waters.
3) Regulate and control the quality management, maintenance, investment and industrial
development policy in food processing entities.
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21. 1. Overview
4) Grant, renew, modify and cancel licenses for the industrial transformation of food,
including beverages and liquors and fishing authorizations, establishing the corresponding
requirements and mechanisms for their granting and control.
5) Propose to the Government, and once approved, direct and control the policy for imports
of raw materials and materials for the industrial production of food and processed food
products and beverages.
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22. 2. Structure
For the fulfillment of its functions, the Ministry of the Food Industry has a structure
that is summarized in:
1) A Central Body with a Minister, as the highest authority, a First Deputy Minister, two
deputy ministers, two General Directorates with six subordinate directions and two
functional directions, 3 independent departments and an Auxiliary Body.
2) Five budgeted units (includes two scientific centers, a school, an inspection office and
internal administration)
3) A Business Group attended by the Minister with 94 state-owned companies (30
from the fishing industry, 36 agri-food, 20 food and 8 that provide technical and
general services)
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23. 3. Public Policies
We work supported within our specific functions in three public policies of which two
are approved and one is in the process of preparation.
1) Fisheries Policy of the Republic of Cuba (approved in February / 2017 and in July /
2019 the Fisheries Law enters into force on August 5/2020 and its communication
strategy is in the implementation phase)
2) Policy for the Industrial Production of Food and Beverages (approved January /
2019)
3) Policy for the importation of industrialized food (in process of elaboration)
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24. 4. Services and Procedures
Attention to the Population Fishing Authorizations
Classify, analyze and process with the automated system specialist all complaints,
complaints and requests that are received in writing, addressed to the Minister of the Food
Industry, Vice-Ministers and Directors of the Central Agency, as well as those received
from of the Central Committee of the Communist Party of Cuba, Council of State, Office of
the Comptroller General of the Republic, National Assembly of People's Power, among
other Bodies and Organizations, to guarantee their registration and control;
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25. References
www.cecmed.cu
www.minal.gob.cu
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