Tuesday, September 30, 2014
Rx-360 Summaries of Legislation, Regulations and Guidances Minimize

Report
Number

Description

Category

Date
Issued

443
Read the Free Rx-360 Summary of the 2013 UPS Supply Chain Survey

Education 13-Jan-14
424  
FDA announces moves to avert drug shortages

 Guidance 01-Nov-13 
416  
Read Rx-360's Summary of FDA's Supply Chain Security Program

 Guidance  28-Aug-13
415  
Rx-360 Summary of ICHQ3D, Guideline for Elemental Impurities; Step 2b

 Guidance  07-Aug-13
414
Rx-360 Summary of the US FDA's implementation of Title VII of the FDASIA (Food and Drug Administration Safety and Innovation Act) 

 Legislation  06-Aug-13
412
Rx-360 Summary of Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products
 Guidance 30-Jul-13 
411
Rx-360 Summary of EU’s Falsified Medicines Directive Rule (Article 46b 2011/62/EU)

 Legislation 30-Jul-13 
409
Rx-360 Summary of the US Congressional Research Services Pharmaceutical Supply Chain Security Report

 Guidance 25-Jul-13
408
Rx-360 Summary of the US FDA's Recently Published a New Guidance for Industry, Heparin for Drug and Medical Device Use

 Guidance 16-Jul-13 
407
Rx-360 Summary of the US FDA's implementation of Title VII of the FDASIA (Food and Drug Administration Safety and Innovation Act)

 Legislation 02-Jul-13 
405
India's List of API Manufacturers Confirmed for Export to EU

 Guidance 22-Jun-13 
404


At the Last-Minute, EU Says US Clear to Export APIs Under Falsified Medicines Directive

 

Legislation 22-Jun-13
401
EMA has issued Q&As addressing GMP requirements for active substances

 Guidance 02-Jun-13
400
Rx-360 Summary of Health Canada New API Regulations

 Regulation  02-Jun-13
398
USP Elemental Impurities Update

 Guidance 28-May-13
397
Rx-360 Summary of FDA Draft Guidance on Contract Manufacturing Arrangements for Drugs: Quality Agreements

 Guidance 28-May-13
396
Rx-360 Summary of the United Nations Transnational Organized Crime in East Asia and the Pacific

 Education 10-May-13
395
Rx-360 Summary of the FreightWatch 2013 Global Cargo Theft Threat Assessment
 
 
 Education 10-May-13
394
Attention Medical Device Supply Chain Security Professionals! Meet with Rx-360 on May 22, 2013

 Education 08-May-13 
391

Free Rx-360 Summary Chart of the European Commission's Falsified Medicines Directive


Education 01-May-13
390

Rx-360 Summary of the US House of Representatives conducted a hearing entitled Securing Our Nation’s Prescription Drug Supply Chain


Legislation 29-Apr-13
389


Rx-360 Summary of Guideline on the Use of Porcine Trypsin Used in the Manufacture of Human Biological Medicinal Products

 

 Guidance 27-Apr-13 
386


Rx-360 Summary of Importation of Active Substances For Medicinal Products for Human Use, Questions and Answers, Version 4.1

 

Guidance 22-Apr-13
385


Rx-360 Summary of New Saudi FDA Guidance for the Storage and Transport of Time and Temperature Sensitive Pharmaceutical Products


Guidance 10-Apr-13
382
Rx-360 Summary of EC Importation of Active Substances for Medicinal Products for Human Use, Questions and Answers

Guidance 07-Apr-13
380
Rx-360 Summary of US FDA Draft Glass Syringe Guidance

Guidance 06-Apr-13
377
Rx-360 Summary of EMA Draft Guideline on Setting Health Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities

Guidance 30-Mar-13
376
Rx-360 Summary of the China SFDA Published a Good Supply Practice Guidance

Guidance 29-Mar-13
374
EMA Released Revisions to 4 GMP Chapters and is Seeking Public Comment

Guidance 22-Mar-13
372
Read the Rx-360 Summary of the New EC GDPs 

Guidance 20-Mar-13
371
Notification on Matters Related to the Implementation of Electronic Monitoring of Imported Drugs

Guidance 12-Mar-13
367


Rx-360 Summary of IOM Report: Countering the Problem of Falsified and Substandard Drugs

 

Education 26-Feb-13
366

 

Read the Rx-360 Summaries of 3 Documents the EC Issued for Public Consultation

 

Guidance 20-Feb-13
365


Rx-360 Summary of FDA Drug Shortages Task Force and Strategic Plan – Federal Register Notice

 

Guidance 12-Feb-13
362

 

Rx-360 Summary of Indian Government Publishes Good Distribution Practices for Pharmaceuticals 

 

Guidance 05-Feb-13
361


ANVISA Requests Feedback On The Conditions For Granting The Certification Of GMP And GDP

 

Guidance 04-Feb-13
352


Rx-360 Summary of U.S. FDA GMPs for Combination Products

 

Guidance 22-Jan-13
351


Rx-360 Summary of the Indian “Guidelines on Recall and Rapid Alert System for Drugs (Including Biologicals & Vaccines)”

 

Guidance 21-Jan-13
348
Brazil’s ANVISA Published Requirement for GMP Compliance by Manufacturers of Pharmaceutical Excipients

Guidance 15-Jan-13
337
President Obama Signed Into Law the Safe Doses Act 

Legislation 28-Nov-12
334
India Finalizes GDP Guidelines for Biological Products 

Guidance 06-Nov-12
332
New EU Q&A on Falsified Medicines Directive

Legislation 29-Oct-12
330
US Senate Publishes Draft Proposal to Improve Drug Distribution Security (Track & Trace Propsal) 

Legislation 25-Oct-12
329
Please Participate in a Rx-360 Survey on EU GMP Part 3 Changes 

 
Legislation 19-Oct-12
325
Read the Rx-360 Summary of The Food and Drug Administration Safety and Innovation Act (FDASIA), Title VII

Legislation 28-Sep-12
324
Read the Rx-360 Summary of the Indian Draft GDP Guidelines for Biological Products

 
Guidance 27-Sep-12
319
Read the Rx-360 Summary of EU GMP Revisions to Chapter 7 on Outsourcing

Guidance 18-Sep-12
310
Rx-360 Summary of Title X of the Food and Drug Administration Safety and Innovation Act Establishes Requirements to Prevent Drug Shortages
 
 
Legislation 17-July-12
309
EMA Publishes 32 Questions and Answers on the Falsified Medicines Act

Guidance 12-July-12
305
The FDA has submitted a formal application to start a supply chain security pilot for drug product and API's

Guidance 26-June-12
304
New ANVISA Draft GMP Requirements for Excipients

Guidance 18-June-12
303
Time and Temperature Sensitive Label to Become Mandatory on 1 July 2012

Guidance 12-June-12
302
G8 nations met at Camp David on May 18-19, 2012 to collaborate against counterfeit medicines

Enforcement 31-May-12
296
Read the Rx-360 Summary of MHRA's Falsified Medical Products Strategy 2012-2015


Counterfeits 17-May-12
295
Read the Rx-360 Summary of The White House's Executive Order -- Promoting International Regulatory Cooperation

Guidance 16-May-12
293
Rx-360 Summary of the FDA Global Engagement Report
Guidance 08-May-12
292
Rx-360 Summary of Draft EMA Process Validation Guidance

 
Guidance 23-Apr-12
N/A
Medicines Control Council of South Africa Publishes Draft Guidance for Distribution of Pharmaceuticals

Guidance 25-Apr-12
286
Read the Rx-360 Summary of US House Draft Bill to Prevent Drug Shortages by Amending the FD&C Act 
Legislation 09-Apr-12
285
Read the Rx-360 Summary of API Regulatory Inspection Sharing Programme
Regulation 09-Apr-12  
282
Rx-360 summary of the recently issued FDA Cut Label Fianl Rule

Guidance 23-Mar-12
281
Rx-360 Summary of PIC/S Recommended Model for Risk-Based Inspection Planning in the GMP Environment

Guidance 16-Mar-12
280
Rx-360 Summary of FDA Drug Shortage Guidance 

Guidance 02-Mar-12
279
Read the Rx-360 Summary of the US GAO Supply Chain Security Report

Guidance 28-Feb-12
278
Read the Rx-360 Summary of the Propsoed USP Chapter 1083 Concerning Supply Chain Integrity

Guidance 27-Feb-12
271


Read the Rx-360 Summary of EC Concept Paper for Importing APIs

Legislative 06-Jan-12
270
Read the Rx-360 Summary of the FDA Interim Final Rule on Product Discontinuance

Regulation 05-Jan-12
269
Rx-360 Summary of US S-1886 Counterfeit Penalty Act
Legislative 05-Jan-12
263
Rx-360 Summary of EC Detailed Rules for a Unique Identifier for Medicinal Products for Human use
Guidance 04-Dec-11
262
Rx-360 Summary of IMB Wholesaler Guidance
Guidance 02-Dec-11
261
Rx-360 Summary of the FDA's Approaches to Medical Product Shortages
Guidance 29-Nov-11
258
Rx-360 Summary of Proposed US HR 3026, Safeguarding American’s Pharmaceuticals Act of 2011
Legislation 21-Nov-11
257
Rx-360 Applauds US Policymakers for Introducing Counterfeit Drug Penalty Enhancement Act
Legislation 18-Nov-11
249
Rx-360 summary of FDA's final guidance on anticounterfeiting excipients
Guidance 26-Oct-11
248
Rx-360 Summary of IMB Guide To Storage And Transportation Temperature Conditions For Medicinal Products And Active Substances

 
Guidance 20-Oct-11
245
FDA releases final guidance on anticounterfeiting excipients

Guidance 12-Oct-11
244
IMB Guide To Storage And Transportation Temperature Conditions For Medicinal Products And Active Substances

Guidance 10-Oct-11
243
Rx-360 Summary of Proposed US Senate Legislation S-1584 Drug Safety and Accountability Act 2011

 
Legislation 07-Oct-11
242
Multi-Agency participation in global efforts to protect consumers and patients from unsafe drugs on the internet

 
Enforcement 30-sep-11
241
New US Draft Pharmaceutical Supply Chain Leglislation Published

Legislation 29-sep-11
240
Rx-360 Summary of FDA Diversion and Counterfeit Criminal Case Information
Benchmarking 28-Sep-11
239
Rx-360 Summary of WHO Annex 9: Guidance for the storage & transport of time & temp-sensitive products
Guidance 11-Sep-11
238
Rx-360 Summary of FDA Bar Code Requirements
Guidance 11-Sep-11
237
Rx-360 Summary of USP  Good Storage and Distribution Practices for Drug Products
Guidance 30-Aug-11
231
Rx-360's Operating Philosophy Agrees with the PIC/S Q&A on API Distribution Activities
Guidance 04-Aug-11
230
Rx-360 is Encouraged by the Progress Regulators Have Made Sharing Inspection Findings
Investigations 03-Aug-11
228
Rx-360 Summary of EU Draft Good Distribution
Guidance 28-July-11
226
Rx-360 Summary of FDA's Modification of Pedigree Requirements

Legislation 25-July-11
225

 

Rx-360 Summary of New Saudi Arabian GMPs

Regulation 20-July-11
223
Rx-360 Summary of New EU Batch Certification Requirements
Regulation 15-July-11
218
Rx-360 Summary of Finalized EU Falsified Medicines Act

Legislation 05-July-11
 217
Rx-360 Summary of US FDA's Pathway to Global Product Safety and Quality

Govt Report 05-July-11
216
Rx-360 Summary of Turkish GMPs/GDPs and Audit Checklist
Regulation 29-June-11
194
Rx-360 Summary of US Proposed Leglisation Drug Safety Enhancement Act of 2011
 
Legislation 28-Apr-11
189
Rx-360 Summary of Counterfeit Pharmaceutical Inter-Agency Working Group Report to the Vice President of the United States and to Congress
Govt Report 04-Apr-11
188
Rx-360 Summary of FDA's Final Guidance for Industry, Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
Regulation 04-Apr-11
185
Rx-360 Summary of Guidance for Industry, Non-Penicillin Beta-Lactam Risk Assessment

 
Regulation 24-Mar-11
182
Rx-360 Summary of European Parliament adopted the amendments on Counterfeit Medicines
Legislation 15-Mar-11
177
Rx-360 Summary of EMA's draft Qualified Person's (QP) Template and associated Q&A
Regulation 23-Feb-11
175
Rx-360 Summary of the EMA Road Map 2015
Regulation 10-Feb-11
169
Rx-360 Summary of Revisions to Annex 11, Compuerized Systems 

 
Regulation 30-Jan-11
165
Rx-360 Summary EU Chapter 5 Revisions 
Regulation 07-Jan-11
158
Rx-360 Summary of Revisions to Chapter 7 of the EU GMP Guide

Regulation 15-Dec-10
153
Rx-360 Summary of International API Inspection Program

 
Regulation 05-Dec-10
 142
Rx-360 Summary of US FDA - Strategic Priorities 2011 – 2015

Data
Sharing
26-Oct-10
137
Chinese State Food and Drug Administration Proposed Route of Registration for APIs, Excipients and Auxiliary Materials

 
Legislation 12-Oct-10
135
Regulators are collaborating and sharing more information than ever before

 
Data Sharing 08-Oct-10
134
New MHRA Guidance on Inactive API Suppliers
Guidance 07-Oct-10
 132
Read the Rx-360 Summary of U.S. Legislation HR 759, the Drug Globalization Act
Legislation 04-Oct-10
109
Rx-360 Summary of Proposed U.S. Legislation S3690, Drug Safety and
Accountability Act of 2010
Legislation 11-Aug-10
108
Rx-360 Summary of Proposed U.S. Legislation HR4678 Foreign Manufacturers Legal Accountability Act of 2010 
Legislation 10-Aug-10
105

 

 


Rx-360 Summary of Proposed US Legislation HR 5740 is now available
Legislation 05-Aug-10
98
Rx-360 Summary of the UPS Supply Chain Survey
Survey 14-Jul-10
97
Rx-360 Summary of U.S. FDA's Draft CMC Guidance Document

Guidance

13-Jul-10

96


Rx-360 Summary of U.S. FDA's Transparency Initiative

Guidance

13-Jul-10

93
Rx-360 Summary of the U.S. China Economic and Security Review Commission Biopharma Report
 

Data Sharing

29-Jun-10

83
Rx-360 Summary of EC Directive 2001/83/EC to Prevent Falsified Medicine
 

Guidance

7-Jun-10

82


From Brazil ANVISA Issues New GMPs with Rx-360 Summary

Guidance

 

 

4-Jun-10

75


U.S. FDA Urges Industry to Take Steps to Prevent Cargo Theft

Guidance

28-Apr-10

73
Rx-360 Summary of US Congressional Hearing - Drug Safety an Update from FDA

Legislative

1-Apr-10

72
Rx-360 Summary of the U.S. FDA Final Guidance on Serialization

Guidance

31-Mar-10

71


Rx-360 Summary of the WHO Guidance on Starting Materials

Guidance

29-Mar-10

61


Rx-360 Summary of EU GMPs: Explanatory Note on Preparation of Site Master Files

Guidance

24-Feb-10

58


Rx-360 Summary of Changes to the “Anti-Counterfeiting Directive” 2001/83/EC Proposal For A Directive Of The European Parliament And Of The Council
Anti-Counterfeiting Directive” 2001/83/EC

Guidance

16-Feb-10

56


Rx-360 Summary of US FDA guidance to avoid drugs shortages involving medically necessary products

Guidance

2-Feb-10

53
Rx-360 Summary to Q & A Guidance for Industry: Pharmaceutical Components at Risk for Melamine Contamination [Supplement to August 2009 Rx-360 Summary on FDA Guidance for Industry: Pharmaceutical Components at Risk for Melamine Contamination]

Guidance 27-Jan-10
52
EU Proposed GMP Changes to Chapter 1 - Quality Management System
     To view or download Chapter 1
click here
     To view or download Rx-360 Summary of Chapter 1
click here
Guidance 20-Jan-10
52


EU Proposed GMP Changes to Chapter Chapter 2 Personnel
  To view or download Chapter 2-  
click here
  To view or download Rx-360 Summary of Chapter 2-
click here  

Guidance  20-Jan-10

49


Rx-360 Summary of the U.S. FDA guidance to avoid drugs shortages involving medically necessary products

Guidance

8-Jan-10

47


Rx-360 Summary of the U.S. FDA Guidance on Residual Solvents

Guidance

29-Dec-09

36


Rx-360 Summary of the U.S. FDA’s Guidance on Melamine Contamination

Guidance

09-Aug-09

35


Rx-360 Summary of the U.S. FDA Issues Pharmaceutical Industry Guidance on Preventing Melamine Contamination

Guidance

06-Aug-09

30


Rx-360 Summary of US FDA's Draft Guidance for Industry on PCIDs

Guidance

21-Jul-09

28


Rx-360 Summary of the U.S. FDA Issues Draft Guidance for Industry on Drug Anti-counterfeiting

Regulation

14-Jul-09

22


Rx-360 Summary of the U.S. Congressman Dingell's New US Draft Legislation HR 759

Legislative

16-Jun-09

18


Rx-360 Summary of the new US Congress Draft Legislation on Supply Chain Security

Legislative

01-Jun-09

7


Rx-360 Summary of the U.S. draft US Senate Drug Device Accountability Act of 2009 – Rx-360 Analysis

Legislative

05-May-09

3


Rx-360 Summary of the U.S. Announcement of US Drug and Device Accountability Act of 2008

Legislative

30-Apr-09

 

    

Rx-360 Summaries of Legislation, Regulations and Guidances Minimize
  

 

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