Pharma Guidelines, ending 10 June 2011

Recently updated and newly issued documents

Human Medicinal Products

Title	Status
Australia
Guide to interpretation of the Code of GMP for the manufacture of 18-Fludeoxyglucose injections Therapeutic Goods Administration, Jun 2011	Final Effective immediately
Canada
Fees for the Right to Sell Drugs Health Canada, 1 June 2011	Final Effective immediately
Czech Republic
UST-36 version 3: Administrative fees, reimbursement of costs for expert activities conducted upon request in compliance with Act No 296/2008 Coll., on Safeguarding the Quality and Safety of Human Tissues and Cells Intended for Use in Man State Institute for Drug Control, 6 June 2011	Final Effective immediately
EU
Concept paper on the need for a guideline on process validation of medicinal products containing biotechnology derived proteins as active substance European Medicines Agency, EMA/CHMP/BWP/25360/2011, 19 May 2011 (posted 6 June 2011)	Draft Submit comments by 31 August 2011
US
Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies Food and Drug Administration, Federal Register, 7 June 2011, 76(109), 32863-32864	Final Effective immediately
Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Food and Drug Administration, Federal Register, 8 June 2011, 76(110), 33309-33310	Final Effective immediately

Sources

Australia: www.tga.gov.au

Canada: www.hc-sc.gc.ca

Czech Republic: www.sukl.cz

EU: www.ema.europa.eu

US: www.fda.gov