In the vast expanse of China's market regulations, the Marketing Authorization Holder (MAH) System stands as a pivotal aspect governing product approvals and market entry. Demystifying this system unveils the keys to navigating China's intricate market landscape.
- February 15, 2024 Pharmaceuticals, Regulatory Affairs
- February 9, 2024 Pharmaceuticals, Publishing & Submissions
The pharmaceutical industry is witnessing a transformative era where global Regulatory harmonization is playing a pivotal role in streamlining medicinal product submissions. This harmonization is not only facilitating the exchange of information among Regulatory authorities but also enhancing the reliance on assessments performed by global regulators.
- February 9, 2024 Pharmaceuticals, Publishing & Submissions
In the ever-evolving landscape of pharmaceutical and medical device regulation, two buzzwords have risen to the forefront: data integrity and cybersecurity. As Regulatory bodies like the FDA and EMA intensify their focus on these areas, companies within the healthcare sector must adapt to meet the stringent requirements for Regulatory submissions.
- February 9, 2024 Food and Food Supplements
In a bold move to combat deforestation and promote sustainability, the European Parliament and the Council have enforced Regulation (EU) 2023/1115. This blog dissects the intricacies of this regulation and its profound impact on the marketing and export of commodities linked to deforestation, particularly affecting the formulation and trade of food supplements.
- February 9, 2024 Medical Devices, Regulatory Affairs
The medical device industry in Korea has been growing rapidly. This growth is a testament to the quality and innovation of medical devices manufactured in Korea, which are increasingly being exported globally. A critical factor in determining the safety and efficacy of Korean devices is their adherence to Korean Good Manufacturing Practices (KGMP), as recommended by the Ministry of Food and Drug Safety (MFDS).
- February 9, 2024 Pharmaceuticals, Compliance, Audit and Validation
In the pharmaceutical industry, data security is paramount to maintaining compliance with regulatory standards and safeguarding sensitive information. With the increasing threat of cyber-attacks, pharmaceutical companies must prioritize cybersecurity measures to protect their data and uphold the highest compliance and patient safety standards.
- February 9, 2024 Pharmaceuticals, Compliance, Audit and Validation
An audit trail is a chronological record of system activities that provides documented evidence of specific events. In the pharmaceutical context, this can include changes to electronic records, alterations in critical parameters, or any other actions that could impact product quality.
- February 9, 2024 Medical Devices
Combination products, which are innovative therapeutic and diagnostic products that combine drugs, devices, and/or biological products, are becoming increasingly prevalent in the healthcare industry. In China, the registration of these products is governed by specific Regulatory frameworks that help ensure their safety, efficacy, and quality.
- February 7, 2024 Pharmaceuticals, Regulatory Artwork Services
In the rapidly evolving pharmaceutical landscape, where innovation meets stringent regulations, accurate and engaging communication is crucial. Enter eLabeling, a digital revolution transforming the way drug information is delivered. Central to this shift is the role of artwork—a crucial component that goes beyond mere aesthetics and delves into compliance, user engagement, and brand representation.
- February 7, 2024 Pharmaceuticals, Regulatory Artwork Services
The pharmaceutical industry is a sea of innovation, constantly churning out new drugs and treatments to improve human health. But just like any voyage, this journey is fraught with Regulatory storms that can threaten smooth sailing. One crucial aspect often overlooked in this tempestuous voyage is the power of Regulatory artwork.