The Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s health Regulatory agency, released new Active Pharmaceutical Ingredients (API) standards in April 2020, including the new Carta de Adequabilidade do Dossiê de Insumo Farmacêutico Ativo (CADIFA) regulations in Brazil.

Recently, the International Agency for Research on Cancer (IARC), the World Health Organization (WHO), and the Joint Expert Committee on Food Additives (JECFA) of the Food and Agricultural Organization (FAO) released assessments on the non-sugar sweetener, Aspartame. These assessments have sparked a contentious debate on the safety of Aspartame, particularly on its potential carcinogenic effects.

Today, in an increasingly globalized world, the international trade of food and dietary supplements is subject to a complex web of regulations and standards. The Southern Common Market, abbreviated in Spanish as Mercosur, is a South American trade bloc comprising Argentina, Brazil, Paraguay, Uruguay, and Venezuela (whose membership has been suspended since 2016).

As you may know, China is a major pharmaceutical market with a growing demand for innovative drugs. However, the Regulatory landscape of the country can be complex and challenging to navigate for new as well. The FAQs mentioned below are designed to provide answers to common questions, which will help you bring your medicinal product to the Chinese pharmaceutical market with confidence.

The United Arab Emirates (UAE) upholds a dynamic cosmetic industry, offering consumers a diverse array of beauty and personal care products. Cosmetic products in the UAE are subject to robust regulations, which are primarily overseen by two (02) key administrative bodies: the Dubai Municipality (DM) and the Emirates Authority for Standardization and Metrology (ESMA).

The development of safe and effective pediatric medication is essential for ensuring that all children have access to the best possible medical care. However, pediatric drug development is a complex and challenging field, and there are several factors that have hindered progress in this area in Japan.

In the European Union (EU), cosmetic products play a significant role in the beauty and personal care industry. To ensure the safety and quality of these products, the EU has put in place stringent regulations, including specific guidelines for cosmetic packaging. Cosmetic manufacturers and suppliers looking to market their products in the EU must understand and comply with these requirements.

Regulatory artwork compliance is of utmost importance in the pharmaceutical industry to ensure patient safety and adherence to Regulatory standards. Pharmaceutical companies must navigate complex Regulatory requirements and maintain compliance throughout the artwork management process.

In the pharmaceutical industry, Regulatory artwork plays a crucial role in ensuring compliance, quality, and patient safety. The creation and management of artwork for packaging and labeling must meet stringent requirements set by Regulatory bodies such as the FDA.

Imagine working on a new drug to treat a devastating disease. After years of hard work, you've finally gathered the data you need to submit a regulatory submission to the FDA. But then, you realize that your electronic records and eSignatures don't comply with 21 CFR Part 11. This is a scenario that no one wants to find themselves in. The world of regulatory compliance is complex and ever evolving.