FDA–Guide to International Pharma Regulations. (English)

In drug manufacturing, success means staying abreast of regulatory changes from Australia to Zimbabwe … and beyond.

Impossible? Not at all.

Guide to International Pharma Regulation is the one-stop authority for quick, accurate answers to all your questions on the fastest moving regulatory topics you face:

Changes in inspection practices
Quality manufacturing standards
New patent regulations
Sunshine and transparency regulations
Tough new bribery laws
Labeling and marketing regulations
Changing pharmacovigilance requirements
Anti-counterfeiting measures
Orphan drug regs
And dozens more key topics in drug regulation worldwide
International compliance is no longer simply a matter of playing by the same old rules.

There’s been a dramatic increase in foreign inspections. Many countries are collaborating via joint inspections and confidentiality agreements that permit sharing of inspection results. And in many countries, drug safety concerns are prompting new requirements. You learn the new rules of the game or cede the playing field to competitors.

That’s where the FDAnews Guide to International Pharma Regulation: 2014 Edition comes in. Our editors monitor and report on regulatory developments affecting drug production in more than 45 nations around the world. They’ve compiled more than 150 reports highlighting changes from the past year that will keep you growing in international markets.

You’ll turn to this total regulatory reference time and again in the months ahead. It will become your one-stop source for:

Coverage of the EU, Asia, Latin America, the Middle East, North America and Australia/Pacific
Essential international regulatory changes from all of 2013
Comprehensive summaries and explanations of the changes
Key regulations – full-text printouts
And much more!
To compete internationally, you must comply internationally. It’s a lesson your competitors have learned. Don’t get left behind. Place your order now.

Publication Details

Format: Print or CD

Price: $387

Four Easy Ways to Order
Please mention priority code 14521 when ordering.

Order online.
Call toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.
Use your American Express, Visa or MasterCard.
Fax your purchase order to +1 (703) 538-7676.
Mail your check to: FDAnews, 300 N. Washington St., Suite 200, Falls Church, VA 22046-3431.

FDAnews, 300 N. Washington St., Suite 200, Falls Church, VA 22046-3431
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