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Archive for ‘May, 2011’

Multifaceted Falsified Medicines Directive Cleared in Europe; Implementation Will Pose Challenges for Industry and Regulators

Legislation adopted by the EU Council on May 27 will significantly strengthen the EU’s ability to detect falsified medicines and prevent their entry into the legitimate supply chain by adding new requirements in four main areas: ● safety features ● supply chain and good distribution practices (GDPs) ● active substances, and ● Internet sales....
May 31, 2011 | Posted in Anticounterfeiting, Europe, Supply Chain/GDPs, The News in Depth | Read More »

EMA’s IMP Guideline Will Provide Shelf-Life Flexibility and EU Harmonization

Two key thrusts of EMA’s “Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials” will be to provide flexibility in shelf-life determination for IMPs and to facilitate harmonization of the clinical trial application process across the EU....
May 27, 2011 | Posted in CMC Review Policy, CMC Standards, Europe, General/Quality, Investigational/Clinical, Post-approval Changes, The News in Depth | Read More »

IPQ’s Monthly Update for April is Now Available

The GMP regulatory umbrella is expanding around the globe to encompass a more defined body of good distribution practices (GDPs) and increased enforcement of supply chain controls. The Monthly Update for April includes six stories on key developments in the industry/regulator effort to better control the global supply chain....
May 25, 2011 | Posted in The News in Depth | Read More »

IPQ Monthly Update — April 2011

The Monthly Update covering the key CMC and GMP developments in the US, Europe and internationally during April is now available....
May 24, 2011 | Posted in Current Issue, Issue Archive, Monthly Update | Read More »

EU Biological Product GMPs Will Expand in Breadth and Depth With New Annex 2

The soon-to-be finalized overhaul of EU GMP Annex 2 will significantly expand the breadth and depth of its coverage of the manufacture of biological products and will bring advanced therapy medicinal products (ATMPs) and those transgenically-derived under its umbrella....
May 18, 2011 | Posted in Advanced Therapy, Biotech Therapeutics, Combinations, Europe, GMP Policy, Product Type Specific, The News in Depth, Transdermal, Vaccines/Biologicals | Read More »

FDA May Ask for More Data on Higher Order Protein Structure in Biotech Applications

As methods and technologies designed to unravel the complexities and intricacies of protein folding, three-dimensional structure and function become more reliable and available, FDA is looking at whether it is time to begin requiring more detailed information on higher order protein structure in biotech product applications....
May 11, 2011 | Posted in Biotech, Biotech Therapeutics, CMC Review Policy, Product Type Specific, The News in Depth, US/Canada | Read More »

Differences in National Shipping Requirements Challenge International Pharma

Pharmaceutical companies are wrestling with how to address the differences in country-specific regulatory requirements for shipping of their products, particularly regarding the allowance for minor excursions from the labeled storage conditions....
May 6, 2011 | Posted in GDP/Supply Chain, GMP Policy, Latin/South America, Purity/Potency/Identity/Stability, Shipping & Storage, Supply Chain/GDPs, The News in Depth | Read More »

IPQ’s Monthly Update for March, 2011 is Now Available

IPQ’s coverage of the developments during March provides a wealth of insights into the quality regulatory challenges posed by products outside the typical pharmaceutical profile – high technology products with complex delivery systems on the one side, and products which elevate standard excipients into the active drug category and/or do not meet the approved drug criteria on the other....
May 2, 2011 | Posted in The News in Depth | Read More »

IPQ Monthly Update — March 2011

The Monthly Update covering the key CMC and GMP developments in the US, Europe and internationally during March is now available....
May 2, 2011 | Posted in Current Issue, Issue Archive, Monthly Update | Read More »

ICH Position Papers Will Address Pressing Issues in Q8-10 Implementation; EU Experience Helps Shed Light

The ICH Quality Implementation Working Group (IWG) is progressing in its effort to develop a series of six position papers covering issues identified by the industry and health agency participants at the 2010 ICH Q8-10 training sessions as needing further clarification. The IWG is planning to complete the six papers by the end of 2011....
May 1, 2011 | Posted in ICH Q8-10/QbD, International, International Harmonization, The News in Depth | Read More »

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