Over the past year, sweeping regulatory reforms have been introduced in China with the aim of encouraging innovation and reducing regulatory burden on the life sciences industry. The breadth of these reforms spreads across multiple stages of the drug development life cycle.
Prescription drug spending increases — fueled by high launch prices for new therapies and price increases for existing brand-name drugs — are contributing to unsustainable healthcare cost growth across the country. In addition to straining the healthcare system overall, high drug prices also place financial burdens on patients who rely on prescription medicines to treat and manage serious and chronic medical conditions.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Involving regulatory affairs early in the development process facilitates execution of the development pathway while considering both regulatory requirements and the company’s business needs.
March 30, 2019 — Brexit D-Day — isn’t as far in the distant future as some might hope. For U.S. pharma companies with headquarters or CROs in the U.K., much needs to be decided, planned, and executed before that time to ensure a smooth transition.
A common misconception in the industry is that an orphan designation is one of the easier regulatory milestones to reach. The guidance the FDA has issued on obtaining an orphan designation is relatively straightforward, perhaps so much so that it is easy to overlook some of its key elements.
The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections to help determine whether statutory and regulatory requirements of the respective authorities have been met.
A holistic view of the value of blockchain to the pharmaceutical supply chain takes into account the magnitude of the global counterfeit drug problem; the financial, economic, and social costs of counterfeit drugs; and the positive financial and economic benefits of moving beyond compliance to tackling the issue of counterfeit drugs head-on.
In October 2017, the European Commission issued a consultation seeking input from the public regarding whether improvements can be made to the patent system. The policy questions underlying patent extensions and research exemptions could have a far-reaching impact.
The November 2017 decision by CMS to change the coding practice for biosimilars in the United States is likely to have far-reaching consequences for these drugs, but will all downstream effects be positive?