Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a new set of regulations that standardizes how cosmetic organizations conduct business and maintain the safety of cosmetic products within a Regulatory framework. In the draft regulation, the enforcement deadline for facility registration is December 29, 2023. There are two (02) different deadlines for new facilities and existing facilities.
- October 17, 2023 Cosmetics Regulatory Services, Regulatory Affairs
- October 16, 2023 Pharmaceuticals, Publishing & Submissions
The increased Regulatory consideration of RWE in NDA/BLA submissions represents a fundamental shift toward a more patient-centric, evidence-based approach to drug evaluation. This approach has the potential to expedite access to life-saving therapies, particularly for those facing rare diseases and unmet medical needs.
- October 16, 2023 Pharmaceuticals, Publishing & Submissions
In the fast-evolving world of pharmaceuticals and Regulatory Affairs, the way companies submit their drug applications to health authorities is transforming. One of the key developments in this realm is the implementation of Electronic Common Technical Documents (eCTD) baseline submissions.
- October 13, 2023 Regulatory Affairs
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.
- October 12, 2023 Food and Food Supplements
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.
- October 12, 2023 Food and Food Supplements
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).
- October 11, 2023 Pharmaceuticals, Regulatory Affairs
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.
- October 11, 2023 Cosmetics Regulatory Services, Regulatory Affairs, Regulatory Labeling
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).
- October 10, 2023 Pharmaceuticals, Regulatory Affairs
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.
- October 9, 2023 Cosmetics Regulatory Services, Regulatory Affairs
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.