Report Number	Description	Category	Date Issued
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 Pain in the 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 CouncilAnti-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