The 2009 PDA-FDA Joint Regulatory Conference opened this morning in Washington, DC, with a keynote address by Dr. Joshua Sharfstein, principal deputy commissioner at the US Food and Drug Administration. Read more »

FDA issued two new proposed rules this week that would require all manufacturers to report adverse events electronically. The idea seems perfectly reasonable—every company uses computers and the Internet these days. But what struck me as odd is that the agency is still entering adverse event reports manually and that paper filings are still being used at all. As an editor, I spend a good portion of my day typing, but I haven’t had to retype or transcribe from a hard copy in years. It’s no wonder FDA has such a backlog of paperwork and lengthy review times. The growing global industry demands fast, electronic communication, and the agency must keep up with the culture. Before they know it, pharma companies will be sending adverse event reports or supply-chain breaches via Twitter—surely 140 characters is enough to note that a patient experienced a negative effect after taking a certain drug product. Read more »

We’ve all heard that quality by design and science/risk-based approaches to pharmaceutical manufacturing require a paradigm shift among industry. Well, that message was reinforced again today at the 3rd Annual Pharmaceutical Technology Conference in Philadelphia, PA. Read more »

I’m here at the 3rd Annual Pharmaceutical Technology Conference in Philadelphia, PA. Hot on the agenda is quality. Quality by design, quality via process validation, quality via life cycle production. Nick Cappuccino presented the first session of the morning on ICH Q8, 9, and 10 implementation. Dr. Cappuccino is a member of the ICH Quality Implementation Group. Read more »

Pfizer (New York) has apparently agreed to settle allegations that it conducted an illegal clinical trial of its meningitis drug trovafloxacin in Nigeria. Eleven children died during the trial that prosecutors say was unlicensed. It would be impossible to establish drugs’ safety without clinical trials in humans, but the settlement agreement is more grist for those who say that trial patients’ rights and health are not sufficiently protected. How will regulators respond? Read more »

An International Conference on Harmonization expert working group met in Brussels last week to discuss Q8(R1) Pharmaceutical Development, the annex to Q8. The addendum document, which provides greater detail on design space, including examples and approaches to take, has moved through the consultation period. According to sources, the guideline is now ready for Step 4 of the ICH process (i.e., or adoption by the three regions’ regulatory bodies and representatives-US, EU, and Japan). Read more »

Just as the ICH steering committee and expert working groups are discussing next steps for the implementation of Q10 Pharmaceutical Quality System and possible adoption of the Q8 annex to Pharmaceutical Development in Brussels this week, ASEAN’s* harmonization scheme is taking another divergent turn. Read more »

This month is quite exciting for those in the pharmaceutical industry paying attention to harmonization and international regulatory efforts—which frankly, should be everyone if your company wants to stay in the game. Last week, PDA/FDA held its annual joint regulatory conference with nearly 20 high-level speakers representing the US Food and Drug Administration, including Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research. Read more »

Quality systems are here, there’s no doubt about it. The outcome of this week’s ICH expert working group meeting is sure to nail down that fact even harder. Taking place in Portland, Oregon, ICH and industry representatives from around the world are expected to discuss next steps for ICH Q10: Quality Systems, which is intended to augment good manufacturing practices in the three ICH regions: Europe, Japan, and the United States. Q10, currently in Step 3 of the ICH harmonization process, which involves working toward regional consensus, is likely to move to Step 4, or regional endorsement. Once in Step 4, an ICH guideline moves immediately to the final stage, Step 5, or regulatory implementation.

Also on the table at this week’s expert working group meeting is ICH Q11: Development and Manufacture of Drug Substances. Read more »