Medsafe oversees pharmaceutical product regulation in New Zealand and operates under the Medicines Act 1981 which mandates sponsors to report substantial untoward effects of their medicines. The requirement for regulations are highlighted in the Guidelines on the Regulation of Therapeutic Products in New Zealand (GRTPNZ) which also has a Pharmacovigilance (PV) guidance document. This provides […]
Pharmacovigilance in New Zealand Read More »
Early-phase clinical trials for cell and gene therapy (CGT) products differ from those for other pharmaceuticals due to unique product features and previous clinical experiences, which have revealed substantial risks, including multi-organ failure, leukemia, and tumor development. Factors such as prolonged biological activity, immunogenicity, and invasive administration procedures contribute to these risks. The design of
Designing Early-Phase Clinical Trials for Cell and Gene Therapy Products Read More »
Human gene therapy products, like other medicines, may be eligible for an orphan drug status or designation provided sponsors can demonstrate that the product can treat a rare disease and that they can prove a scientific rationale basis for product’s effectiveness in treating the rare disease. If the eligibility criteria is met, then the orphan
Navigating Orphan Drug Regulations for Gene Therapy Products Read More »
Join DDReg at the Biotech Beach of the world! Meet the team at the BIO International Convention and DIA Global Annual Meeting to discuss clinical, regulatory, and safety requirements. San Diego, often known as the “Biotech Beach,” has been a thriving center for biotech for several reasons. Its coastal location and the presence of numerous
DDReg Features in BioPharma Dive: At the Forefront of Biotech and Pharma Read More »
Brazil is emerging as an attractive location for clinical research as it offers access to a range of patient demographics and medical facilities due to its diverse population and robust healthcare infrastructure. Conducting clinical trials for investigational products is a meticulous and highly regulated process, requiring sponsors to adhere to stringent guidelines. This ensures the
Conducting Clinical Trials for Investigational Products in Brazil Read More »
Regulatory agencies across the globe are committed to ensuring that patients and the public have timely access to safe, effective, and high-quality medicines. They make significant developments, be it revision of guidelines to provide industry with robust support & guidance or expediting review and response times. Recently, the US FDA issued a guidance document for
Controlled Correspondence for Generic Drug Development Read More »
Human gene therapy represents a groundbreaking frontier in medicinal products for treating complex diseases. This therapy aims to transform gene expressions or modify cellular properties for therapeutic purposes. Regulatory agencies support this innovation by ensuring the required guidelines are in place. For example, the US FDA stands as a guiding beacon for sponsors that wish
CMC Considerations for Human Gene Therapy INDs Read More »
Biological products are derived from living organisms or cells encompass a wide array of essential medical interventions, including vaccines, gene therapy products, and blood derivatives. Thus, these products are relatively complex in nature which is why there is a need to maintain heightened vigilance and continuously monitor their safety and efficacy. It is crucial to
Commitment to Biological Product and Patient Safety in India Read More »
Advanced rare disease drug developers are companies or organizations that specialize in the research and development of treatments for rare diseases. Developing drugs for rare diseases poses unique challenges due to small patient populations, genetic variations, and the need for novel endpoint selection. In response, the FDA has allocated resources through initiatives like Prescription Drug
Empowering Rare Disease Drug Developers Read More »
The Association of Southeast Asian Nations (ASEAN) region presents an attractive opportunity for global pharmaceutical organizations that are looking to obtain market access in the respective ASEAN markets. This is due to its rapidly expanding healthcare market and harmonized regulatory processes. DDReg is thrilled to announce a significant stride in its commitment to supporting its
DDReg Opens Entity in Singapore Read More »
