ELS Group – Accelerating Innovation

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

ANVISA Resolution No. 964 was published in the Federal Official Gazette (DOU) on February 24, 2025, establishing general requirements for conducting Forced Degradation Studies on medicines containing synthetic and semi-synthetic active pharmaceutical ingredients (APIs). The resolution also defines the parameters for the notification, identification and qualification of degradation products in these drugs. Below, we summarize the most important points of this new regulation.

By Marketing ELS|2025-03-09T22:37:36+00:009 de March, 2025|ANVISA`, brazil, ELS Group, General, Geral, Notícias, regulations|0 Comments

Portugal’s Health Sector Exports Grow 21.6%, Surpassing €4 Billion in 2024

Portugal's health sector has recorded impressive growth in exports in 2024, surpassing the 4,000 million euro mark, which represents an increase of 21.6% on the previous year. This increase reflects the dynamism of the sector, which remains strong even in a challenging global context.

By Marketing ELS|2025-03-09T22:22:32+00:009 de March, 2025|ELS Group, Geral, Infarmed, News, Notícias|0 Comments

ELS Group hosts webinar on the medicinal cannabis market in Europe

Join ELS Group for an Exclusive Discussion on the Future of Cannabis in Europe!

By Marketing ELS|2025-03-11T10:44:23+00:003 de March, 2025|ELS Group, Geral, Infarmed, Medical Devices, News, Notícias|0 Comments

New Rules for Medicine Export Control in Portugal

INFARMED has introduced stricter export controls to prevent medicine shortages. Wholesale distributors must report exports, while manufacturers and pharmacies face less bureaucracy. These measures align with EU regulations, ensuring transparency and protecting national supply.

By Marketing ELS|2025-02-28T17:05:04+00:0028 de February, 2025|ELS Group, Geral, Infarmed, Medical Devices, News, Notícias|0 Comments

EMA Establishes Procedure for Scientific Advice on High-Risk Medical Devices

EMA has announced the implementation of a new standard procedure for scientific advice for manufacturers of high-risk medical devices.

By Marketing ELS|2025-02-24T12:00:26+00:0024 de February, 2025|ANVISA`, ELS Group, Geral, Medical Devices, News, Notícias|0 Comments

PGEU has published the 2024 Medicine Shortages’s annual report

The PGEU has reported widespread medicine shortages across all 28 countries in 2024, with pharmacists spending more time managing the issue.

By Marketing ELS|2025-02-24T11:12:17+00:0024 de February, 2025|ANVISA`, brazil, ELS Group, General, Notícias, regulations|0 Comments

Medicines Shortages in Europe: PGEU Report 2024 Points to Critical Scenario

The PGEU has reported widespread medicine shortages across all 28 countries in 2024, with pharmacists spending more time managing the issue.

By Marketing ELS|2025-02-24T10:54:01+00:0024 de February, 2025|ELS Group, News, Notícias, regulations|0 Comments

New Regulation on Medicine Availability in Portugal

Resolution No. 233/2025 updates medicine availability regulations, strengthening supply chains and export controls to prevent shortages in Portugal.

By Marketing ELS|2025-02-21T16:18:43+00:0020 de February, 2025|ANVISA`, brazil, General, Notícias, regulations|0 Comments

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

With Resolution RDC No. 947, Anvisa aims to reduce costs associated with storing and digitizing physical documents, while ensuring the authenticity and integrity of the documents by requiring the use of electronic signatures.

By Marketing ELS|2025-02-19T12:31:24+00:0019 de February, 2025|ANVISA`, brazil, General, Notícias, regulations|0 Comments

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

The Medicines Market Monitoring System (Sammed) is open for 2024 H2 marketing report submissions. Meet the March 14, 2025 deadline to qualify for the 2025 drug price adjustment.

By Marketing ELS|2025-02-19T10:10:55+00:0019 de February, 2025|ANVISA`, brazil, General, Notícias, regulations|0 Comments