Pharma regulation 2025: Digital transformation, AI, and global harmonization reshape the compliance landscape
Regulatory agencies worldwide are embracing cloud technologies and AI to streamline approvals, strengthen data integrity, and accelerate innovation (Issue #330, 1,065 words, 5.2 minutes)
Good morning, and welcome to the NPC Healthbiz Weekly e-newsletter from the National Pharmaceutical Congress and Chronicle Companies.
In a year defined by seismic shifts in technology and policy, pharmaceutical regulators are rewriting the rulebook. Cloud computing and artificial intelligence — once buzzwords, now boardroom imperatives — are transforming how new therapies reach the market, with agencies racing to modernize oversight while keeping patient safety at the forefront. The result? Faster drug approvals, more intelligent surveillance, and a new era of global harmonization that promises to redraw the boundaries of innovation and compliance for an industry in flux.
A Deloitte report highlights the growing convergence of regulatory standards across regions as a key trend for 2025, driven by initiatives such as the International Council for Harmonization (ICH) and collaborative frameworks including the Access Consortium. These efforts try to streamline regulatory processes by reducing variability in requirements, enabling companies to conduct multinational trials more efficiently and accelerating the path to market.
However, regulatory fragmentation can hinder innovation and delay patient access to new treatments, prompting global regulatory agencies to intensify harmonization efforts. Swissmedic, the regulatory authority in Switzerland, is deeply involved in these efforts, according to Pharma Boardroom. In an interview with the website, the agency’s executive director, Raimund Bruhin, emphasized the importance of international collaboration, particularly through the Access Consortium, which includes Canada, Australia, Singapore, and the U.K., as well as the U.S. FDA’s Orbis initiative. He said these partnerships enable shared assessments of scientific documentation, reduce processing times, and improve access to innovative therapies.
Pharma in Brief reports that regulatory modernization aligns with a global shift toward more adaptive, risk-based frameworks in Canada. Recent amendments to the Food and Drug Regulations and Medical Devices Regulations introduce dynamic terms and conditions, replace product-specific rules for biologics with broader safety requirements, and expand the use of rolling reviews for drugs targeting public health emergencies. These amendments are designed to formalize pandemic-era flexibilities and strengthen quality assurance.
According to Deloitte, real-world evidence (RWE) is playing a growing role in regulatory decision-making, with agencies increasingly expecting its integration in new drug applications and label expansions. This shift enables faster approvals, particularly for rare diseases and complex conditions, and is driving a need for new expertise within regulatory affairs teams. The report also notes that companies increasingly incorporate genetic and genomic data into their broader clinical development programs, using advanced analytics to strengthen regulatory submissions and advance precision medicine initiatives.
Life Science Academy reports that sustainability and globalization influence the evolving regulatory landscape. Environmental factors have become central to manufacturing and development processes, with green chemistry and carbon-neutral practices increasingly being recognized and integrated into regulatory frameworks. The website highlights that emerging markets are a major driver of global pharmaceutical growth, pushing companies to adjust their strategies to meet diverse regulatory landscapes and patient needs.
THIS WEEK 05/13/25
The U.S. FDA approved Verastem Oncology’s avutometinib capsules and defactinib tablets (Avmapki Fakzynja Co-Pack) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who received prior systemic therapy.
Apotex launched Melphalan hydrochloride injection 90 mg/mL multidose vial (IVRA). IVRA is an alkylating drug indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. It. It will be distributed primarily through hospital and institutional channels.
HLS Therapeutics entered into an agreement with Esperion Therapeutics to in-license and commercialize bempedoic acid (Nexletol) and bempedoic acid and ezetimibe (Nexlizet) in Canada. Both medications are indicated to help reduce low-density lipoprotein cholesterol levels and cardiovascular risk in patients who can’t take recommended statin therapy.
Satsuma Pharmaceuticals and its corporate parent, Shin Nippon Biomedical Laboratories, announced the U.S. FDA approved a 505(b)(2) New Drug Application for dihydroergotamine (DHE) (Atzumi nasal powder for the acute treatment of migraine with or without aura in adults). Atzumi was previously known as STS101.
NOW, LISTEN UP: HERE’S BETTINA HAMELIN OF INNOVATIVE MEDICINES CANADA
In season 14 of the NPC Podcast, Dr. Bettina Hamelin, President of Innovative Medicines Canada, gives insights into adopting innovative technologies, the domestic supply chain for pharmaceuticals, and excluding medicines as retaliatory measures for tariffs. Hear her in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.
HEALTHBIZ REWIND
This feature of NPC Healthbiz Weekly looks back at some of the most insightful moments from previous NPC Podcast episodes. You can listen to the podcast here.
Lisa Mullet
Senior Vice-President
Sumitomo Pharma Canada
Canada
Season 13, episode 05
Listen to this episode here
What bold predictions do you have for the life sciences industry during the coming 12 or 24 months?
I think it's important that we embrace what the future is bringing. Some of the technologies and learnings we've gained are shaping the development that's happening now. From my perspective, AI is in every facet of our society, and it's only going to accelerate in our industry. It's helping with drug discovery, patient care, commercial activities, you name it. We have to embrace it. We have to embrace the ability to accelerate the good we do and the opportunity to help more patients. This industry is changing rapidly, and I truly believe it is for the better. We just have to ensure that the good we are all trying to do stays on a path that serves patients, supports our businesses, and, more importantly, helps us win against the fate of disease. I've been at this for 30 years, and seeing patients do well because of the work we do brings me incredible pride.
NEXT WEEK
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