INFO KGV | LIFE SCIENCES APRIL/MAY 2020

COVID-19: ANVISA RELEASES TECHNICAL NOTE ON CLINICAL TRIALS AND BIOEQUIVALENCE STUDIES

 

On 23 March 2020, the Brazilian Health Surveillance Agency (ANVISA) published a technical note (Portuguese language) that provides guidelines for sponsors, research centers and investigators regarding the conduct of clinical trials authorised by ANVISA and bioequivalence studies the during the COVID-19 pandemic.

ANVISA aims to enable the safe and rapid conduct of clinical trials and bioequivalence studies in Brazil, considering the extraordinary measures adopted to contain COVID-19 that may interfere with clinical trials, such as the isolation and quarantine of study subjects, shutdown of research centres and shortage of supplies used in clinical trials.

The key guidelines provided within the technical note are:

• Safety of trial subjects must be guaranteed. The conduct of clinical research shall be maintained in accordance with Good Clinical Practices.
• Sponsors may decide jointly with investigators and ethics committees whether a subject may continue to participate in a particular clinical trial, for the purposes of protecting that subject.
• Considering the social isolation measures, those responsible for clinical trials shall evaluate whether there are alternative methods for conducting safety assessments to guarantee patient safety, for example, by telephone contact, virtual visit, or utilising an alternative site for assessment, such as local laboratories or imaging centres.
• All necessary deviations from the clinical protocol resulting from the measures adopted to combat COVID-19 shall be registered.

The FDA’s “Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” was used by ANVISA a reference when drafting the technical note.

 

NEW RESOLUTION ON EXPORTATION AND IMPORTATION OF DRUGS SUBJECT TO SPECIAL CONTROL

Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados

 

On 8 April 2020, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No 367/2020 (Portuguese language) which establishes criteria for both:

• The exportation and importation of substances, plants and drugs subject to special control.
• The grant of Special Simplified Authorisations for teaching and research institutions, including for clinical trial purposes.

The existing legal basis related to the international trade of substances, plants and drugs subject to special control was segmented in several norms, which created difficulties in monitoring and complying with the standards. In addition, there was a need to improve, modernise and harmonise procedures related to the international control of these products.

Resolution RDC No 367/2020 provided for a review that updated and modernised the technical aspects related to those norms, which contributed to the clarification of the regulatory process and ensured more effective control.

The new rule proceedings will be applicable to all companies that export or import substances, plants and drugs subject to special control, for any purpose, as well as to teaching and research institutions that undertake studies of these products.

The following products and services are specifically not covered by the new rule:

• Isotope and radioisotope analytical standards.
• Analytical standards of isotopically marked organic substances.
• Kits for in vitro diagnostics and for the detection of substances subject to special control.
• Non-drug formulations containing substances on the D1 list of ordinance No 344/1998.
• Substances on the D2 list of Ordinance No 344/1998, which are subject to control and inspection by the Ministry of Justice.

Resolution RDC No 367/2020 will enter into force on 4 May 2020, revoking Resolution RDC No 201/2002, Resolution RDC No 99/2008, Resolution RDC No 11/2013 and Resolution RDC No 62/2016.

 

COVID-19: MINISTRY OF HEALTH PUBLISHES ORDINANCE ON TELEMEDICINE

Beatriz M A Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados

 

On 23 March 2020, the Ministry of Health (MoH) published Ordinance No 467/2020 (Portuguese language), which regulates and operationalises the use of telemedicine in response to the COVID-19 pandemic.

Considering the social isolation measures adopted to contain COVID-19, the MoH recognised the necessity of enabling and regulating the use of telemedicine in Brazil for circumstances other than those already provided for by the Federal Council of Medicine’s Resolution CFM No 1.643/2002 (Portuguese language).

Some of the key points set forth by MoH ordinance are the following:

• The distance interaction provided by telemedicine may include: (i) pre-clinical attendance; (ii) assistance support; (iii) medical appointment; and (iv) monitoring and diagnostics within the Brazilian Unified Health System, as well as in the supplementary and private system of health.

• Physicians are authorised to issue digital medical certificates or prescriptions through telemedicine.

• The digital appointment must be registered in a clinical record, which shall contain: (i) the patient’s clinical data; (ii) the date, time and communication technology used for the digital appointment; and (iii) the doctor’s professional data.

Ordinance No 467/2020 entered into force on the date of its publication.

 

ANVISA PUBLISHES RESOLUTION ON GMP OF ACTIVE PHARMACEUTICAL INGREDIENTS

Beatriz M A Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados

 

On 1 April 2020, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No 362/2020 (Portuguese language), which establishes the criteria for Good Manufacturing Practice (GMP) for international establishments that manufacture active pharmaceutical ingredients (APIs) obtained by plant extraction, chemical synthesis, classic fermentation or semi-synthesis. Resolution RDC No 362/2020 also implements the international API inspection programme.

The purpose of the new resolution is to raise the level of API regulation in Brazil and, thus, provide patients with drugs of better quality and safety, since most of the APIs used in Brazil are produced by international companies.

According to Resolution RDC No 362/2020, the certification of GMP will depend on the fulfillment of requirements established by GMP rules such as those in Resolution RDC No 39/2013. The decision regarding the certification referred to in the new resolution will depend on the verification of the fulfillment of the requirements recommended by the current standards of API GMP, by means of one of the following measures:

• Evaluation of the documents listed in Section 3 of Resolution RDC No 362/2020 for companies inspected by the relevant authority of a country recognised by ANVISA as equivalent in relation to the measures and controls applied to confirm compliance with GMP of APIs.

• Evaluation of the documents listed in Section 3 of Resolution RDC No 362/2020 and conduct of a risk assessment that justifies the issuance of a GMP certificate.

• Evaluation of an inspection report issued by ANVISA as a result of conducting an in loco inspection because of the need of a risk assessment, or the absence of an inspection report under the terms of item VIII of Section 3 of Resolution RDC No 362/2020.

With regard to the inspection programme, the new rule establishes that ANVISA can conduct a sanitary inspection at an API manufacturer at any time, regardless of the certification process. The refusal to receive the sanitary inspection will lead to an administrative proceeding, in which the importation, use and marketing of the API can be suspended and the company’s products can be recalled.

Resolution RDC No 362/2020 will enter into force on 3 August 2020.

 

COVID-19: ANVISA PROVIDES DIGITAL PLATFORM FOR REQUESTING APPROVAL TO MARKET, IMPORT AND MANUFACTURE CANNABIS-BASED PRODUCTS

Beatriz M A Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados

 

On 8 April 2020, the Brazilian Health Surveillance Agency (ANVISA) established that approval for marketing, importing and manufacturing cannabis based-products can be requested through the Unified Federal Government Portal (Portuguese language), a digital platform.

The request must be submitted through the ANVISA’s “Solicita System”, and the entire process is carried out without the need for a face-to-face filing process. The measure reinforces ANVISA’s commitment to protect the health of the institution’s companies and employees in the face of the COVID-19 pandemic.

ANVISA’s digital approval allows companies to sell cannabis-based products for up to five years. In addition to authorisation, digital services are also available to change or cancel existing authorisations.

COVID-19: ANVISA AUTHORIZES QUICK TESTS IN PHARMACIES

Beatriz M A Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados

 

On 29 April 2020, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No. 377/2020 (Portuguese language), which authorises the use of quick tests (immunochromatographic tests) for COVID-19 in pharmacies, on a temporary and exceptional basis.

According to the Resolution, only quick tests approved and registered by ANVISA can be used and these tests cannot be adopted as a confirmatory diagnosis of COVID-19. Pharmacies must also comply with the following requirements:

• The test must be carried out by a pharmacist.

• The pharmacy must be licensed by ANVISA.

• The pharmacy must comply with ANVISA’s pharmaceutical good practices and security proceedings.

• The registration and traceability of the test results must be guaranteed.

• The pharmacy must inform public authorities of the test results.

ANVISA also issued a note (Portuguese language) providing clarification on the registration procedure for quick tests for COVID-19 and explaining why pharmacies are allowed to use them. Pursuant to the note, the use of the tests at pharmacies will permit the implementation of prevention policies, increase access to tests, reduce costs and encourage social distancing.

ANVISA’s decision to temporarily allow quick tests in pharmacies has been confirmed by a Brazilian court. The decision (Portuguese language) issued by the Fifth Federal Court of Distrito determined the shelving of the lawsuit that requested Resolution RDC No. 377/2020 to be suspended, recognising the importance of wide access to quick tests and the possibility of administering them in pharmacies.

Resolution RDC No. 377/2020 has already entered into force and will be automatically revoked when the Ministry of Health declares the public health emergency to be over.

 

ANVISA ISSUES SERVICE ORIENTATION ON OTC DRUGS CLASSIFICATION

Beatriz M A Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados

 

On 4 May 2020, the Brazilian Health Surveillance Agency (ANVISA) issued Service Orientation No. 83/2020 (Portuguese language), which establishes the procedure for analysing requests for over-the-counter (OTC) drug clarification.

The Service Orientation was issued in accordance with Resolution RDC No. 98/2016 (Portuguese language), which sets out:

• Criteria to classify drugs as OTC.
• Procedures for market authorisation holders requesting reclassification of their product.
• ANVISA’s duty to update the OTC drugs list.

The Service Orientation aims to expedite the analysis of requests for OTC drug classification according to Resolution RDC No. 98/2016, as well as comply with deadlines agreed through Resolution RDC No. 336/2020 and Decree No. 10,178/2019. The Service Orientation is based on the following:

• The requests shall be organised in groups by matter (for example, drugs with the same therapeutic indication or manufactured with the same active pharmaceutical ingredient) allowing the same discussion for multiple requests.

• The analysis must observe the eventual characteristics of the drug that permitted its classification as OTC by the following international medicines authorities: the FDA; Japan’s Pharmaceuticals and Medical Devices Agency; the Swiss Agency for Therapeutic Products; Health Canada; and Australia’s Therapeutic Goods Administration.

• Drugs not classified as OTC by the specified international medicines authorities must have their requests completely analysed in accordance with Resolution RDC No. 98/2016.

• Once observed that the drug cannot be classified as OTC, the analysis can be discontinued.

The Service Orientation is a result of contributions by associations and entities related to the regulated sector.

 

“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”