Quality Systems

Attention around pharmacovigilance transformation potential has tended to focus on automating discrete steps in the case-processing pipeline. End-to-end ICSR autonomy may enable near-instantaneous case processing so that current SUSAR targets become obsolete.

As quality control labs move toward more connected, data-driven operations, digital technologies must be adopted in a way that upholds patient safety.

The EMA’s annual report shows the agency approved 104 human drugs in 2025 that included first-in-class and first-in-indication therapies.

Molly Klote, Klote Medical Research Advisors, discusses how pharma must move beyond tariff-driven reactions to build evidence-based, quality-led supply chain resilience that satisfies FDA scrutiny and protects patient access.

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explains why radiopharmaceuticals are unique for patients with cancer and what makes them challenging to develop for those patients.

The standards organization’s annual drug shortages report finds drug shortages lasting longer and the number of discontinuations rising, but the number of shortages themselves have gone down.

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.

Regulatory reform, patient access, and supply chain security were 3 of the key themes showcased this week on PharmTech.com.

Tom Sellig, Adare Pharma Solutions, shares how the CDMO is positioning for growth amid US reshoring and oral dose innovation trends.

At CPHI Americas, Molly Klote, Klote Medical Research Advisors, spoke about how the pharma industry faces tariff volatility and reshoring pressure. She warned FDA wants actionable supply chain plans, not slogans, with quality built in.

Changes in regulations are reducing costs, expediting approval, and increasing the market for biosimilars.

EMA, AMA, and national regulatory authorities in Africa are working on potential clinical trial designs and medical treatments for the Ebola outbreak in the DRC and Uganda.

CMC teams can align with Q5A(R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant safety.

The organization’s set of product-specific biologics emerging standards are available on its Emerging Standards Platform for public comment.

FDA instability, staff turnover, and evolving review standards are reshaping drug development. Richard Pazdur, formerly with the FDA, shares what sponsors need to know now.

The new draft guidance allows for the use of publicly available information and established platform knowledge in regulatory submissions for cell and gene therapies that use genome editing in human somatic cells.

This week's news and expert commentary shows that regulatory timelines are tightening, strategic capital is moving into new therapeutic categories, and long-standing operational gaps are demanding real solutions.

PharmTech takes a look back at US and European regulatory news from the month of May 2026.

Dr. Christine Allen, Co-Founder and CEO of Intrepid Labs, and Dr. Andrew Lewis, Chief Scientific Officer of Quotient Sciences, explain how AI can be used in drug development to shorten development timelines.

FDA extends AstraZeneca’s camizestrant's review deadline to assess additional data after its advisory committee failed to reach a majority vote in April.

The CMA will improve Europe’s manufacturing resilience and lead to greater diversification and reduced reliance on single external suppliers.

Pharmaceutical serialization must evolve from regulatory compliance into operational intelligence, addressing hidden failures like exception overload, certificate expiry, and 3PL complexity.

Quantum chemistry is accelerating drug discovery AI by providing physics-based, reproducible, and scalable data that encodes molecular reality.

Bristol Myers Squibb collaborates with Anthropic to accelerate drug development, manufacturing quality systems, and regulatory documentation via AI integration.

Deborah Smook, co-founder and co-owner of TurboFil Packaging Machines, explains some of the challenges involved with prefilled syringe manufacturing.