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Chile Drug Product Registration

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Chile Drug Product Registration

Safeguarding Public Health Through Comprehensive Regulation

MoH

Ministry of Health of Chile

MoH Website

http://www.minsal.cl/

Regulatory Agency

Agencia Nacional de Medicamentos (ANAMED)

Regulatory Agency Website

https://www.ispch.gob.cl/anamed/

License Validity

5 Years

Pharmaceutical Product Classification

  1. Chemical or Synthetic product
  2. Biological Products
  3. Radiopharmaceutical products
  4. Phytopharmaceuticals
  5. Homeopathic Products

Other pharmaceuticals

Overview

  • Manufacturers need to register and receive market authorization from the Agencia Nacional de Medicamentos (ANAMED) in order to enter the market. The Chilean market, however, presents a difficulty for international firms to negotiate the revised regulatory procedures to fall in compliance, since there are constantly changing regulations and competitive schedules.
  • According to Article 20 of DS 3/10, before being disseminated or utilized on national territory, pharmaceutical items imported or produced in the nation must first obtain a health registration.
  • To verify a product’s quality, safety, and efficacy, a pharmaceutical specialty’s health registry involves a systematic evaluation and study of its pharmaceutical, pharmacological, toxicological, and clinical properties. The process results in a registration in a special role with correlative numbering, which is maintained by the Institute and permits the product’s distribution and use throughout the nation (Article 18 DS 3/10).
  • The registration request can be made manually, by inputting the information in the office of the Institute of Public Health (ISP) or electronically, through the “Online Computer Processing System” which is available at https: / /www.ispch.gob.cl/sistema-informatico-de-tramitación-en-line . _
  • DS 3/10 provides the conditions for pharmaceutical product registration. However, there are two types of applications to submit:
  1. Ordinary registration application.
  2. Simplified registration application.
  • The application may be submitted by regular registration, streamlined registration, or shortened registration, per DS 3/10.

Investigational new Drug application

Clinical Trial Application

  • The Clinical Trials division of the sub-department of Sanitary Registration and Authorization of ANAMED under the Institute of Public Health of Chile (ISP) is responsible for evaluating the use of pharmaceutical products without national marketing authorization.
  • This division/section also monitors the 6 activities of the centers and laboratories that carry out these kinds of human studies, as well as the revisions that must be made to authorize the use of pharmaceutical goods in clinical research.
  • The phase I, II, and III clinical trials proving the safety and efficacy of the pharmaceutical products intended for marketing authorization should be included when applying for the registration, per the Decree named “Approval Regulations of the National System Control of Pharmaceutical Products for Human Use”.
  • When applying for registration, studies proving the bioavailability or therapeutic equivalency of pharmaceutical products containing active components must be included.

Authorization process of Clinical trial

  • The ISP’s online information management system, GICONA (https://gicona.ispch.cl/giconaweb), allows for the manual or electronic processing of authorization and registration processes. A subscription is necessary to receive a password for system access if the individual or business submitting the registration/authorization request is not presently a user of this online system. Payment is also performed over the internet system when the GICONA is utilized.
  • Institute of Public Health (ISP) reviewer’s judgment or judgment call plays a major role in approving authorization.

Priority Review

Not specified in regulation

Review Period

Not specified in regulation

Required Dossier

The following conditions must be met to import and utilize experimental drugs:

  • Approval letter written by Ethics Committee (Comité de Ética) which is corresponding to the area where the research center is located
  • Letter of the Director of Service (Director del Servicio) to another Committee (if applicable)
  • ICF (Informed Consent Form) dated, signed and stamped by the Ethics Committee
  • Protocol in English and Castilian
  • Investigator’s Brochure in English and Castilian
  • Current Certificate of GMP (Good Manufacturing Practices) of the manufacturer
  • Summary of the manufacturing process (if biological products)
  • A copy of the letter to the PNI (National Immunization Program) (If vaccines)
  • Delegation of functions of the sponsor (if applicable)
  • Proposed labeling
  • Simple statement of the applicant stating that the information submitted are true.
  • Proposed labelling.

New Drug Application

Procedure

  1. After submitting the corresponding fee, the application for marketing permission and any other information needed, depending on the kind of pharmaceutical product, must be submitted to the Institute of Public Health (ISP) using the approved forms.
  2. An application must be mentioned on a written or electronic file which includes documents submitted by applicants, stating the time and date of presentation with a reference number for tracking and reference purposes, upon payment of the fee corresponding to the first admissibility phase of the application.
  3. After examining the application and the supporting documentation, the ISP provides a statement about the acceptability of the information within 10 business days. The applicant will be notified of the choice to move on with the payment of fees associated with the subsequent stage of the process after the application is accepted for additional review.
  4. The application will be sent to the relevant department for a separate analysis of the technical and administrative data after the registration procedure is accepted. The legal consulting department will be the primary investigator of the administrative records, including the legal papers created in Castilian or translated versions signed by the company’s chief technical officer, an appointed expert, or the legal representative. Technical records pertaining to the specifications for technical data, pharmaceutical quality, safety, and efficacy of the pharmaceutical product, along with any additional specific records mandated by the product type, will be segregated and sent to designated technical offices for assessment.
  5. If the evaluation results are positive, the applicant will be notified within six months following the resolution’s adoption, at which point their request for registration will be approved.

The proper marketing authorization of a pharmaceutical product contains the following information:

  • Name and address of the marketing authorization holder.
  • Name and address of the manufacturer, importer, manufacturing or packaging pharmaceutical laboratory, quality control laboratory, distributor, and licensor, if applicable
  • Registration number.
  • Name of the pharmaceutical product.
  • Full qualitative and quantitative composition.
  • Pharmaceutical form.
  • Therapeutic group.
  • Storage conditions and effectiveness period Packaging and presentations.
  • Authorized therapeutic indications.
  • Prescribing and retail conditions pursuant to regulations of Ministry of Health.
  • Whether the product is subject to legal control, batch control or others with information regarding the situation.
  • Authorization restrictions concerning the validity of the registered product and the need to supervise the use thereof
  • Specific obligations of the holder
  • Obligation to inform about the first batch of production or import for distribution in any shape or form
  • Additional relevant info on the manufacturing, import, quality assurance, storage, distribution, or delivery of pharmaceutical products, as well as the safeguarding of confidential information, may be important, contingent upon the characteristics and particular makeup of each product.

A stamped attachment or several must contain the following: approved graphic labeling, the patient information sheet or insert, the healthcare professional information leaflet, the specifications, and the testing methodology of the final product. These attachments are regarded as part of the registration certificate.

Rejection and procedure for appeal

Depending on the type of pharmaceutical product, an application may be denied if it does not comply with the above-mentioned conditions and any additional restrictions. The ISP will notify the applicant of any information needed to complete the authorization processes. The ISP will either move on with additional evaluation of the application or ultimately reject it if the applicant does not submit within 5 working days.

The following situations might result in the marketing authorization application being denied:

  • Incidental issues: the applicant has 15 working days from the date of notification to provide any necessary comments, following which the ISP provides the definitive resolution.
  • Inadequate testing or inadequate information: the applicant will be notified and required to furnish more information within 30 working days. If the information meets the requirements mentioned above, the marketing authorization will be approved.

The ISP requests the Ministry of Health to order the registration’s rejection if the required supplementary information is not provided within the allotted time frame, or if the requested information is provided within the time frame but is again found to be insufficient. The Ministry of Health then provides the ISP with a report on the registration refusal within ten business days of it being issued. The applicant will receive notification from the ISP after the resolution has been passed based on this.

Priority Review

Not specified in regulation

Review period

Within 6 months from the date of payment of the corresponding fees.

Required Dossier

  1. Administrative Requirements

The following general administrative requirements should be fulfilled by a marketing authorization application, together with the accompanying details:

  • Identification and address of the applicant, and legal representative in the case of legal entities.
  • Name of the technical officer in charge of the entity requesting the registration or, if not applicable, of the professional responsible for the technical information provided.
  • Name of the pharmaceutical product including:
  1. trade name, generic or common international name, or otherwise the pharmacopeial or chemical name;
  2. pharmaceutical form;
  3. unit dose per pharmaceutical form; and
  4. route of administration
  • Class or therapeutic group, further indicating the corresponding anatomical-therapeutic classification.
  • Manufacturing system, including:
  1. domestic manufacture, for products manufactured in a legally and technically qualified pharmaceutical laboratory, whether it is made at its own premises or by third parties
  2. Imported products, including:
    • imported finished products made in foreign nations, either directly or through approved third parties.
    • Imported semi-finished goods in their original main packaging that will be fitted in Chile by approved third parties or directly.
    • imports in large quantities that will be packaged in Chile either directly by licensed third parties or in their final pharmaceutical form.
    • Import semi-manufactured goods in order to directly or through approved third parties participate in further manufacturing operations in Chile that are required to acquire a final product.
  • If the license is used to pursue the registration, the licensor must be identified by the name that appears on the license.
  • The manufacturer’s name and address, whether it is domestic or foreign
  • Product presentations that outline the components or equipment needed for administering various packages, including retail, clinical, and/or medical simples, are available.
  • Physical description of the packaging material, including information on the main and secondary packing materials as well as any additional components or administration-related devices, if any.
  • Legal papers signed by the company’s chief technical officer, designated professional, or legal representative in Spanish, or translated copies thereof, comprise the following:
  1. For products imported during any stage of the production process:
    • Pharmaceutical product certificates, marketing authorization certificates, official certifications recommended by the World Health Organization, and certificates of marketing authorization issued by the legally recognized authorities of the country of origin attesting to the manufacturing facilities’ compliance with national marketing laws, the product’s registration in the nation in accordance with current regulations (which include the complete approved formula), and the existence of any restrictions on the product’s sale, if any, under special marketing supervision or under a restrictive regime.
    • signed an official manufacturing agreement between the foreign manufacturing pharmaceutical laboratory and the applicant.
    • Legalized license, if applicable.
    • Unless such information is included in the document mentioned in e.i herein, an official certificate issued by the competent health authority of the country where the manufacturing facilities are located attesting to the foreign manufacturer’s legal authorization in that country and their adherence to Good Manufacturing Practices in accordance with WHO recommendations. The certificate should specify the production areas or product types authorized for manufacture.
    • legalized import contract signed in front of the appropriate public notary, if required.
    • Notarized manufacturing and/or domestic distribution agreement with the relevant sanitary authorization for each facility attached.
    • Quality control agreement entered with a pharmaceutical laboratory authorized by tyee Institute and executed before a notary public, if applicable
  1. For domestically manufactured products
  • a manufacturing and/or domestic distribution contract signed in front of a notary public, together with the relevant facility-specific marketing permission.
  • Legalized license, if applicable.
  • Quality control agreement signed in front of a notary public, if appropriate, and with a pharmaceutical laboratory approved by the Institute.
  1. Technical information requirements

Regarding the pharmaceutical product’s technical details, the application for marketing permission must satisfy the following general requirements:

  • Spanish-language clinical and pharmaceutical monograph signed by the chief technical officer or technical adviser
  • Spanish-language draft of a graphic label designed for retail, clinical sales, and medical samples. A draft of the professional information booklet for healthcare providers supported by pertinent scientific evidence. If the active components in pharmaceutical goods are subject to this criterion, the findings of bioavailability and therapeutic equivalency studies must be provided.
  • A patient information sheet draft that is supported by pertinent scientific facts
  1. Pharmaceutical Quality Requirements

The following general requirements must be satisfied for the marketing permission application to attest to the product’s pharmaceutical quality:

  • pharmaceutical product’s qualitative and quantitative makeup in the following order:
    • Quali-quantitative statement for each active ingredient
    • Quali-quantitative statement for each excipient
    • Qualitative statement of any excipient used and removed during the manufacturing process, if applicable.
    • Quali-quantitative composition expressed in metric system units of mass or volume, or units of biological activity. Whenever possible, the biological activity must be indicated per unit of mass or volume.
    • The names listed in pharmacopoeia or by their INNs (International Non-proprietary Names) must be used to identify active components and excipients. It is necessary to use the Spanish chemical name for non-pharmacopoeial drugs. There are no markings or acronyms that may be used to identify the active components.
    • Any colorants used in the product must be identified by their chemical or generic names. The colorants may also be identified by other names that have permitted colorants indices in line with the applicable national technical standard that has been approved by the Ministry of Health. When using colored capsules, the same rule is applicable.
  • The following details on the active substances used in the production of pharmaceutical goods need to be provided:
    • Specifications and quality control methods, conforming to the requirements listed in official texts, pharmacopoeias or in pharmacopoeial monographs, are currently valid.
    • in Chile Supplier and manufacturer of the active ingredients, including an analysis report detailing all the characterizing parameters of the active ingredient
    • Origin of the primary reference standard, including the corresponding certificate of analysis indicating at least its origin, potency, traceability and other relevant characterizing tests
    • Spectrogram or chromatogram of the active ingredient and the standard obtained by any instrumental method, if applicable.
    • Storage conditions of the active ingredient used as raw material.
  • Specifications and control procedures for each excipient that adhere to the guidelines provided in pharmacopoeias, official texts, or pharmacopoeial monographs that are currently in effect in Chile
  • The analytical methodology in Castilian is signed by the expert who prepared the application, the pharmaceutical laboratory’s quality control manager, or the supplier under contract.
    • Depending on the manufactured pharmaceutical form, the analytical technique must describe the pharmaceutical product and incorporate controls as needed to ensure its quality.
    • All pharmaceutical products must have the following standard test techniques included in their analytical methodology: titration, performance or activity of active substances, identification of contaminants, if relevant, sensory description (appearance, size, shape, color, odor, etc.); description of the type and material of both primary and secondary packaging
    • Specific test methods according to the pharmaceutical farm must be prepared according to current additional technical standards issued by the ISP.
    • The methodology must be validated, if not described in officially recognized pharmacopoeias.
  • Special tests:
    • Modified-release pharmaceutical forms, such as delayed-release or enteric prolonged-release forms and others, must be indicated as such and endorsed by pharmacokinetic, dissolution or dissemination tests, or other studies.
    • Therapeutic equivalence and bioavailability studies, in the case of pharmaceutical products comprising active ingredients subject to this requirement.
  • Fact sheet with analytical data and acceptance criteria describing the product and which, when officially adopted, must be the standards that the final product must satisfy for its useful life.
  • The following suggested duration of efficacy, as well as the conditions for packing and storage of the pharmaceutical product and the reconstituted product, if relevant, are supported by the respective stability tests:
    • The Guiía de Estabilidad de Productos Farmacéuticos, a technical standard approved by the Ministry of Health at the proposal of the ISP, provides stability information such as the following: the identity of the manufacturer and the entity or person responsible for conducting the stability test; temperature and humidity conditions; packaging material and batches (minimum of three batches); test design and analytical procedures; and specifications of the finished product.
    • Stability data for the formulation, the solvent (if included in the presentation), and the reconstituted product should be attached when it must be diluted before administration. It is necessary to provide the suggested solvents in case the product needs to be diluted and the solvent is not included in the packaging. Stability tests for both the formulation and the reconstituted product must also be submitted.
    • All that must be filed is a compatibility study for the necessary diluents if the product must be diluted for immediate administration.
    • The findings of forced degradation tests conducted under stress circumstances, in addition to the above-mentioned requirements, may be relevant in the event of an active component that is not included in the approved formula of a registered pharmaceutical medicine.
  • Technical details on the product’s manufacturing code, quality assurance, and physical-chemical data are provided in a record sheet with flow charts and process controls.
  • The ISP will adhere to the pertinent guidelines in the following pharmacopoeias and their supplements to ascertain the identity, potency, purity, stability, and other physical, chemical, microbiological, and biopharmaceutical criteria for medications for which a registration is requested:
  1. a) Chilean Pharmacopoeia.
  2. b) International Pharmacopoeia.
  3. c) European Pharmacopoeia.
  4. d) United States Pharmacopoeia and the National Formulary.
  5. e) British Pharmacopoeia.
  6. f) French Pharmacopoeia.
  7. g) German Pharmacopoeia.
  8. h) German Homeopathic Pharmacopoeia.
  9. i) Wilmar Schwabe Pharmacopoeia.
  10. j) US Homeopathic Pharmacopoeia.
  11. k) Mexican Homeopathic Pharmacopoeia.

1) Japanese Pharmacopoeia.

  1. m) Spanish Pharmacopoeia.
  2. n) Mexican Pharmacopoeia.
  • In addition, title 21 of the United States “Code of Federal Regulations” (CFR), Section 1.1, and the technical reports of the World Health Organization Expert Committee on biological, biotechnological, chemical, radioactive, and similar standards will be used for the above-mentioned purposes. The ISP has the authority to accept or reject, in whole or in part, the technical information provided by the applicant with appropriate justification if the pharmaceutical product in question is not included in any of the previously mentioned official papers. Tolerances and other requirements must be mentioned in the registration application if the official texts do not define them. This will allow the Institute to determine whether the specifications are enough.

  1. Safety and Efficacy Requirements

The application for marketing authorization is required to include information on the safety and efficacy of the product:

  • studies on the creation of the pharmaceutical product, including tests that are relevant to the suggested formulation and provide justification, such as chemical, pharmaceutical, and biological tests.
  • Preclinical trials, such as those carried out in vitro on experimental animals, are often intended to get more data to determine whether larger-scale research involving humans should be done without placing them in unnecessary danger.
  • Selective pharmacological studies in animals.
  • Tests for carcinogenesis, mutagenesis, embryotoxicity, fertility, and any other assays are required for an accurate assessment of a pharmaceutical product’s safety and tolerance.
  • Phase I, II, and III clinical studies confirm a medication’s safety and effectiveness before it is approved for registration. Trials using items that don’t match the registration formula are still acceptable if the relevant investigations have shown the products’ therapeutic and pharmacological equivalents.
  • pharmacokinetic examinations, if relevant.
  • Studies proving a pharmaceutical product’s bioavailability or therapeutic equivalency must be submitted for registration if the product contains active components that must meet these criteria.
  • Chemical, pharmaceutical, and biological report comprising analytical, chemical, physical, chemical, biological, or microbiological tests to ascertain whether the product to be registered satisfies the stated composition and quality requirements, and whether the suggested control methods align with current scientific understanding, the pharmaceutical form and formulation is appropriate for the intended uses, and the container is appropriate for preservation.
  • A study on pharmacology and toxicology that includes preclinical research detailing the product’s toxicity and established pharmacological characteristics
  • a clinical report prepared by independent experts evaluating the applicant’s tests for the product’s appropriate tolerance, the accuracy of the dose suggested, and any potential negative effects or contraindications.

2.Generic Drug Approval Application

  • The marketing authorization of generic drugs may be according to the ordinary approval process (“New Drug Application” in this document), the simplified approval process (“Simplified Registration Procedure” in this document), or the abbreviated approval process (“Short Registration Procedure”) in this document.
  • The process for registering a pharmaceutical product will vary depending on its type (NDA for novel active ingredients, dosages, or delivery methods; Simplified procedure if similar products already approved share the same ingredients, dosage, and delivery method; Short procedure if Ministry of Health requests it for the implementation of public health plans and programs, or if the active ingredient is added to the National Formulary).

Priority Review

Not specified in regulation

Review period

Within 6 months from the date of payment of the corresponding fees.

Required Dossier

Depending on their kindness and nature, all pharmaceutical goods that need a marketing license should adhere to the same standards. Regarding the generic medications, please refer to the different specifications listed in the preceding section.

Priority Review

Short Registration Procedure

  • Priority review is applicable to medications in the following situations: severe illnesses and life-threatening ailments; and when medications are deemed to be reasonably expected to improve healthcare quality based on an assessment of the target disease’s overall severity and medical usefulness.
  • When a request for marketing permission is filed, consideration is given to the advice of outside specialists.

Simplified Registration Procedure

  • If the interested party requests it, the standard registration process can be streamlined by omitting some details, as shown below:
    • Information on safety and efficacy may not be submitted for pharmaceutical products that have the same active ingredient, in the same amounts, pharmaceutical form, and route of administration as another registered product whose registration has not been revoked by the ISP for public health reasons, unless the ISP determines through a sustained decision that some or all of this information is required. Therapeutic equivalency studies for pharmaceutical products with non-standard release should be submitted.
    • Information on pre-clinical studies may be substituted with the relevant bibliographies in the case of well-known active compounds that have undergone extensive testing, allowing their effectiveness, safety, and adverse responses to be thoroughly examined in the scientific literature. Furthermore, scientific data concerning the safety and effectiveness of the product that is meant to be registered may also be partially omitted; in such an instance, the Institute will examine the application and justifiably demand all relevant data.
    • If a pharmaceutical product is included under active components for which proof of therapeutic equivalency has been demanded and is pharmaceutically equal to a registered product, the related studies must be provided in accordance with certain criteria.
    • The information on safety and efficacy may be omitted if a product was made in Chile solely for export, even though it is recognized as a pharmaceutical product under Chilean regulations and a food product in the country of destination as certified by the appropriate health authorities. However, only if the Institute determines through a well-supported decision that some or all of this information is necessary.
  • The simplified marketing authorization procedure will not be applicable in the following cases:
    • Apart from the well-recognized active components, the pharmaceutical product that must be registered seems to include the active ingredient that is being used for the first time in Chilean medicine.
    • The pharmaceutical product that must be registered shares an active component with another, and Section 2, Title VIII of Law No. 19,939, protects information about such products from disclosure.
    • usage, dose regimen, extending a previously authorized delivery method, or age range. The pharmaceutical product that needs to be registered has different active ingredient concentrations and compositions than those in a registered formula; it also includes new salts, esters, complexes, or isoforms of the active ingredients in a registered pharmaceutical product; or it consists of mixtures of fixed-dose active ingredients that are either separately registered or unregistered.
    • If the pharmaceutical product that must be registered is in a different pharmaceutical form, its active component release has been altered.
    • When a pharmaceutical product is mixed and needs to be registered for the first time.
    • while asking for a biological product to be registered.
  • The simplification of the homoeopathic medicinal product registration process is contingent upon fulfilling the following requirements:
    • The administration might be done externally or orally.
    • Lack of explicit treatment indications on patient information sheets or in the visual labeling for healthcare professionals.
    • The product is made up of one homoeopathic ingredient diluted to an extent that ensures the medication’s safety.
    • It is a homoeopathic material that is used in medicinal products. from a plant, animal, mineral, or chemical substance, as well as from raw materials mentioned in pharmacopoeias that are formally recognized and follow homoeopathic production techniques that are likewise detailed in these sources.

Fees

Products

Fees

General approval of pharmaceutical products

$279.125

General registration of pharmaceutical products

$837,375

Approval of simplified application of pharmaceutical products

$216,195

Simplified registration of pharmaceutical products

$646.555

General approval of phytodrug or other pharmaceutical products (Art. 53)

$216,195

Approval of simplified application of pharmaceutical products or other phytodrug (Art. 52)

$194,492

Simplified registration of pharmaceutical product or other phytodrug (Art, 52)

$571,480

General approval of of homeopathic pharmaceutical product (Art. 53)

$114,970

General registration of homeopathic pharmaceutical product

$343,495

Approval of simplified application of homeopathic pharmaceutical product (art 54)

$20,358

Simplified registration of homeopathic pharmaceutical product (Art. 54)

$94,758

Abbreviated application of pharmaceutical product registration

$216,195

Short pharmaceutical product registration

$646,555