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NewsMarketing ELS2023-12-15T01:15:43+00:00

New historical and regulatory milestone for cannabis in Brazil: ANVISA publishes new RDCs (Collegiate Board Resolutions) and advances the regulation of medicinal cannabis.

Exports of Medicines Temporarily Suspended to Ensure National Supply

Anvisa promotes direct consultation on new regulatory framework for medical devices

Public Consultation on Medicinal Cannabis Products: Anvisa’s Main Proposals

Anvisa publishes new resolution on Good Manufacturing Practices for Medicines

Public Consultation on the Revision of RDC 327/2019: Main Changes and Criticisms

Decree-Law No. 23/2025: New Rules for Cosmetic Products in Portugal

Anvisa Returns to Publishing Medical Device Price Monitoring Data

ELS Group Named Finalist for the 2025 Sindusfarma Quality Award in Two Categories

EMA and HMA Present Strategy for Medicines Regulation in the European Union until 2028

European Commission Presents Critical Medicines Act

Update on Prior Notification of Medicines Transactions Abroad

ANVISA Resolution No. 964/2025 published: Requirements for Forced Degradation Studies on Medicines

PGEU has published the 2024 Medicine Shortages’s annual report

New Regulation on Medicine Availability in Portugal

RDC No. 947: Anvisa Shifts to 100% Digital Protocol Processes

Sammed available for 2024 H2 Marketing Report Submission – Ensure Compliance for 2025

Anvisa updates the Reference Medicines List.

European Shortages Monitoring Platform: A New Era in Medicine Management

FDA Proposes New Front-of-Package Nutrition Label to Help Consumers Make Healthier Choices

APMC Conducts Innovative Study on Medicinal Cannabis for Osteoporosis and Chronic Pain in Women

European Commission Launches Public Consultation on Medical Devices and In Vitro Diagnostics Regulations

Resolution No. 954: Changes to Drug Registration Take Effect

EU Regulation 2021/2282 on Health Technology Assessment Enters into Force

FDA Proposes Draft Guidance to Ensure AI Credibility in Drug and Biologic Submissions

Anvisa Updates Procedures for Borderline Products

Portugal is the second-largest exporter of medicinal cannabis in 2024

EMA launches a public consultation on the use of real-world data in the regulation of medicines.

Progress in Clinical Research in Brazil: New ANVISA Regulations

Anvisa publishes panels on Dossier Adequacy Letter for Active Pharmaceutical Ingredients

Anvisa updates form for importing Cannabis-derived products

Modified the list of medicines with suspended exports

DGAV clarifies the use of biocides in the food sector

Anvisa simplifies registration and entry of Mpox vaccines

INFARMED changes medicines for export

INFARMED changes prices with new homogeneous groups

European Commission examines Falsified Medicines Directive

Supervision of medicines in Spain gains recognition

Cosmetic product labels in Portugal have changed

Update the means of requesting GMP Inspection and AIM from Italy

AEMPS publishes resolution on Allergenic Medicines

EU publishes ‘Consensus Statement’ on Medical Devices

Infarmed approves two new ACMs for cannabis formulas

First nasal medication to treat anaphylactic reactions

EMA proposes approval of 10 new drugs

The list of medicines whose export is suspended has been updated

Anvisa publishes a new procedure for medicines

Anvisa bans phenol in medical and aesthetic treatments

Framing and reframing the regulation of medicines

Anvisa temporarily suspends transfer of ownership

Regulatory Impact Analysis on Cannabis approved

Anvisa approves regulations for biosimilars

Protocole the Import License after NCM reclassification

Report approved to revise regulations on imported goods

SP approves cannabidiol and tetrahydrocannabinol protocol

Anvisa to use external analysis to register medical devices

Decree-Law implements EU regulation on medical devices

Anvisa prioritizes registration of dengue devices

Anvisa extends the validity period of the Good Practices Certificate

Infarmed approves marketing of three cannabis products

Anvisa joins the OAS Program – Full integration

Anvisa – Innovative new regulations for the food sector

Anvisa announces selection of innovative medical devices

Anvisa to update regulations on tartrazine on labels

FDA launches ingredients directory for food supplements

Anvisa publishes GGMED Management Report

Begins biological task force on Optimized Analysis Project

Anvisa publishes sunscreen regulation manual

Medicines and clinical research approved in 2023

Anvisa – 25th anniversary of the Generics Policy

Reports assess risk and benefit of drug list

Anvisa approves new Covid-19 vaccine

Anvisa publishes new edition of the Biosurveillance Manual

Brazil to be present at 15 global food fairs in 2023

Anvisa approves new treatment for advanced cancer in Brazil

Anvisa allows use of packaging and label reserves

Updating the Brazilian Pharmacopoeia

Joint operation to combat illegal imports

Cofepris facilitates access to innovative medicines

Viminol is now a controlled substance

MАРА inspects trade in smuggled wines

МАРА seizes counterfeit olive oil and beans with impurities

Anvisa to support the development of new medical devices

МАРА seizes 9,000 bottles of fraudulent olive oil in Paraná

Anvisa updates application form for import by express shipment

FDA proposes to revoke authorization on the use of BVO in food

Anvisa updates Import Approval with Pre-Shipment requirement

Anvisa: New Measures to Ban Cosmetics used in Injectable Form

Anvisa Regulates the Import of Regularized Medical Devices

Cofepris – New Regulatory Safety Strategy for Medical Devices

Anvisa – Changes in RDC 821/2023 and IN 258/2023

RDC 653: Changes to the transportation and storage of medicines

Anvisa warns about aesthetic products used in injectable form

Cofepris authorizes new influenza vaccine for seniors

Sindusfarma calls for new regulatory framework for drug labeling

Infarmed authorized innovative medicine for several types of cancer

Warnings to prevent antibiotic breakouts this winter

Cofepris detects 7 new irregular drug distributors in the country

Our team were present at FISA in São Paulo!

New rules for drug labeling in Brazil

Malaysians to intensify bilateral trade in health products with Brazil

Drug for HIV Treatment Authorized in Therapeutic Extension

EU-US Agreement on Simpler Rules for Veterinary Products Trade

Our team was present at Naturaltech in São Paulo!

Prior Notification of Transactions in Medicines has been updated

ANVISA suspends products from food supplement company

ECDC and EMA make joint statement on updating COVID-19 vaccines

Advancing regulatory science in the EU

Cultivation of Marijuana for Medicinal Purposes

Top 5 Technological Innovations in Dentistry in 2023

151 Medical Devices and 7 Clinical Trials were approved

Medical robotics market to reach $24.6 billion by 2025