Regulatory Affairs

Putting together a risk assessment for nitrosamines in your final drug product is an extensive undertaking. Many contributing factors need to be considered, such as the drug substance’s manufacturing process, excipients, buffers, water, production equipment and environment, transportation conditions, packaging, and more. Within this scope, primary packaging components, such as elastomeric closures, also could contribute nitrosamines or precursors.

The Standing Committee of the National People’s Congress in China passed the revised Drug Administration Law (Revised Law) on 26-Aug-19. Effective 1-Dec-19, it is the first overhaul since 2001.The Revised Law addresses the major issues in the pharmaceutical industry, demonstrating the government’s efforts in strengthening supervision to ensure drug safety.

随着医药科技不断发展和进步，中国的药品审评标准在不断改变和提高，过去的药品审评标准没有强制要求仿制药与原研药质量和疗效一致，所以有些药品在质量、疗效上与原研药存在一定差距，需要改进提高。自2015年开始，国家药品监督管理局（原国家食品药品监督管理总局）推出仿制药质量和疗效一致性评价，借以提高我国仿制药的质量和疗效。质量和疗效视为等同于原研产品的仿制药将在公立医院的招标和处方中享受优先待遇。

West strives to be the world leader in the integrated containment and delivery of injectable medicines. The achievement of this goal relies on many factors, including a heightened awareness of industry and regulatory trends. By being able to anticipate these trends, West is better able to support its customers with the knowledge and services needed to ensure that drug products reach market on schedule.

For the healthcare industry, the last decade has brought profound changes that continue to shape how drugs are discovered, developed and commercialized. At West, we pride ourselves on helping customers manage change by continuously delivering innovative products and services. Our company keeps close tabs on industry trends to anticipate unmet need in the market and, when appropriate, to disrupt existing value networks.

Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.  In part 2 of this blog series, some of the key takeaways will be discussed in more detail.  Q12 is intended to help companies demonstrate increased product and process knowledge, and understand which post-approval changes will require a regulatory submission, as well as the level of reporting for each category.