The OTC Health and Wellness Conference was held on the 3rd of November 2023. Organized by the Organization of Pharmaceutical Producers of India (OPPI) at the PHD House in New Delhi, it aimed to address the need for self-care and support consumers with evidence-based information regarding the safety of over the counter (OTC) medicines. The […]
DDReg attends the OTC Health and Wellness Conference 2023 Read More »
Japan has a robust regulatory framework for pharmaceuticals and medical devices, which includes specific requirements for In-Country Clinical Caretakers (ICCC). Foreign manufacturers that wish to penetrate the Japanese market must appoint an ICC, who resides in Japan, to sponsor the clinical trials on their behalf. Thus, they play a crucial part in ensuring that foreign
Japan PMDA: The Role of In-Country Clinical Caretakers Read More »
The cosmetics sector in South Korea has witnessed impressive expansion and gained global acclaim. The Ministry of Food and Drug Safety (MFDS) has implemented a strong regulatory system, primarily overseen by the Cosmetics Act, to guarantee the safety and quality of cosmetic items. The Cosmetics Regulatory Framework, in conjunction with additional regulations, plays a crucial
Regulatory Framework for Cosmetics in South Korea Read More »
At the turn of the millennium, guidelines for post-marketing safety reporting of herbal medicines were introduced by the World Health Organization (WHO) in the period between 1999 and 2001. The fact that more than 158 million people in the United States alone spent over 17.6 billion dollars on herbal medicines in the year 2000 is
Pharmacovigilance in Herbal and Alternative Medicine Read More »
CPHI Barcelona was held on 24th to 26th of October 2023 and brought together industry leader, experts, and key stakeholders under one roof to discuss some of the key innovative trends in the industry. DDReg was among the industry experts to have attended the conference and engage insightful meetings and networking opportunities. CPHI Barcelona is
DDReg attends CPHI Barcelona Read More »
DDReg is thrilled to announce its successful nomination for the India 5000 Best MSME Awards 2023. The awards are more than just honours. They provide a platform to Micro, Small, and Medium-Sized Businesses (MSMEs), to showcase their commitment to excellence and professionalism. The nomination of DDReg for the India 5000 Best MSME Awards 2023 demonstrates
DDReg nominated for India 5000 Best MSME Awards 2023 Read More »
Biopharmaceutical product labelling is a multifaceted undertaking that spans various products and markets, encompassing diverse formulations and dosages. The challenge lies in consistently upholding pharmaceutical labelling compliance throughout this intricate process. Ensuring pharmaceutical labelling compliance involves following regulatory requirements and guidelines when developing and updating product labels, such as Summary of Product Characteristics (SPC), Patient
Supporting Labelling Compliance with Searchable Databases Read More »
Real-World Evidence (RWE) refers to clinical evidence derived from real-world data (RWD) collected outside of traditional clinical trial settings. The significance of RWE in regulatory decision making has been growing worldwide due to its potential to provide valuable insights into the safety, efficacy, and effectiveness of therapeutic products. While traditional clinical trials remain the gold
Swissmedic: The Importance of Real-World Evidence in Regulatory Decision Making Read More »
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a significant milestone in the regulation of cosmetic products in the United States. This comprehensive legislation, enacted to enhance consumer safety, imposes a series of requirements and obligations on cosmetic companies, facilities, and responsible persons within the industry. MoCRA not only expands the authority of
Modernization of Cosmetics Regulation Act Read More »
The safe and effective use of medical devices in healthcare facilities is not merely a matter of convenience; it is a moral obligation. The welfare of patients and the quality of healthcare services depend on the responsible use of these devices. Accidents involving medical devices can have dire consequences for patients. These accidents may result
Ensuring Safe Use of Medical Devices in Healthcare Facilities Read More »
