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Drug Registration Process in Ecuador

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Drug Registration Process in Ecuador

Drug Registration Process in Ecuador- ARCSA- Agencia Nacional de Regulation, Control y Vigilance Sanitaria

MOH

Ecuador Ministry of Health

MOH Website 

https://www.salud.gob.ec/

Regulatory Authority

Agenica Nacional de regulacion, control y vigilancia sanitaria (ARCSA)

Regulatory Website

https://www.controlsanitario.gob.ec/

Local Representative Required

Yes

                                                      Drug Registration Process 

1. Initial Submission

The National Agency for Health Regulation, Control, and Surveillance (ARCSA – Agencia Nacional de Regulation, Control y Vigilance Sanitaria) receives applications for drugs in Ecuador. The application contains extensive information regarding the drug’s composition, manufacturing method, results from preclinical and clinical trials, and labeling.

2. Technical Evaluation

ARCSA performs a comprehensive technical review upon application receipt. This entails evaluating the provided data to confirm adherence to Ecuador’s legal specifications. In this step, the drug’s effectiveness, safety, and quality are carefully assessed. Requests for more details or explanation may result from inconsistencies or shortcomings in the application. 

3. Analysis and Approval

Following the technical assessment, ARCSA analyzes the supplied medication samples in a lab. The purpose of these analyses is to verify the drug’s quality and accuracy relative to the data in the application. The ARCSA approves the medication’s registration in Ecuador if it successfully completes these assessments.

Registration Certificate Issuance

The drug’s registration certificate is issued by ARCSA once the evaluation and approval procedures have been successfully completed. With the help of this certificate, the pharmaceutical product is approved for sale and distribution in Ecuador and meets all legal requirements. 

Post-Registration Surveillance

ARCSA continues to conduct post-registration surveillance even after the drug has been registered. By continuing to monitor the pharmaceutical product, safety, efficacy, and quality criteria are maintained. ARCSA must be notified as soon as possible of any adverse reactions or new safety issues pertaining to the medication.

Pharmaceutical businesses looking to launch their medicines in Ecuador must fully comprehend and adhere to the nuances of the drug registration process. To protect the public’s health, strict laws and extensive assessments are in place, guaranteeing that the people of Ecuador can only obtain safe, high-quality drugs.

Generic Approval Process

1. Pre-Submission Activities

Engage in pre-submission talks with ARCSA to better understand regulatory requirements and seek help on application preparation.

2. Application submission

Prepare and submit a generic drug application to the ARCSA. The application normally includes detailed information on the drug’s safety, efficacy, quality, and production practices.

3. Review of the application

ARCSA thoroughly reviews the submitted application, evaluating the scientific and technical evidence to ensure that the generic medication satisfies the necessary requirements for safety, efficacy, and quality.

  1. Bioequivalence Assessment

If the generic medicine is based on bioequivalence data, ARCSA may study and evaluate this information. Bioequivalence studies are required to demonstrate that the generic medication has the same pharmacokinetics and pharmacodynamics as the reference listed drug (RLD).

4.Inspection of manufacturing facilities

ARCSA may inspect manufacturing facilities to ensure that Good Manufacturing Practices (GMP) are followed and that the manufacturing process is consistent and of high quality.

5.Approval phase

If the generic medicine passes the review procedure, ARCSA will approve it for marketing and commercialization in Ecuador.

Data Required for Biologic Product Application

 1.Administrative and prescription information.

2.Summary of common technical publications.

3.Quality information.

4.Studies on the physicochemical and biological characterization of active medicinal ingredients and finished products.

5.Pharmacovigilance programme (risk management plan).

6.Non-clinical comparability studies of biosimilar medicines to reference biological medicines should comprise at least:

6.Toxicity

7.Pharmacokinetic and pharmacodynamic research in at least one appropriate animal model.

8.Local tolerance test.

9.Immunogenicity investigations and reporting are conducted in accordance with the ICH recommendations.

Labelling Requirements for Biosimilar

1.Name of Medicine

2.International Non-Propriety Name

3.Route of Administration

4.Dose

5.Pharmaceutical State of Product

6.Lot Number

7.Temperture Storage conditions

8.Manufacturer Information

9.Manufacturing and Expiration Date

10.Prepration and use Instructions.

11.Type of Biologic medicine (vaccine, Blood products etc.)

12.Quantitive Formula of Each Ingredients

13.Warn

Documents

1.Certificate of free sale

2.Certificate of Analysis

3.Pharmacological Reports

4.Immunological Reports

5.Toxicity Reports

6.Pharmacodynamics Reports

FSC Required– Yes

Registration Timeline –2-6 Months

License Validity-5 Year

Registration Fee– 904.34 US dollar

Renewal of License –Six Months

Labelling Requirements- Labelling must in Spanish 

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