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Comment Requested on Recall Regulations

FDA issued a request for comment on its recall regulations and their estimated reporting burdens in early August. FDA explicitly invites comments on: ● whether proposed collection of information is necessary for the proper performance of the agency’s functions ● the accuracy of FDA’s estimate of the burden of the proposed collection of information ● […]

Cocrystals Reflection Paper Open for Comment

A reflection paper on the use of cocrystals in drug products was opened for comment by EMA at the end of July. The paper clarifies EMA’s position on cocrystals as API’s by giving definitions and discussing the regulatory implications of using them.

FDA Cautioning Industry on Looming Initial Track and Trace Deadlines

FDA is cautioning industry stakeholders that the initial implementation phase for the track and trace provisions in the Drug Quality and Safety Act (DQSA) is rapidly approaching, with interoperable product transaction requirements for manufacturers, distributors, and repackagers kicking in on January 1, 2015....

APEC’s Assessment of Gaps in Supply Chain Regulation Reveals Surprising Differences in Country Approaches

The assessment by the Asia Pacific Economic Cooperation (APEC) organization of the gaps in the ability of regulatory agencies to address the problems of an international supply chain has revealed some surprising differences in their practices....

India Offers Bounty for Whistleblowers on Fake Medicines

In a mid-July circular, India’s Central Drugs Standards Control Organisation (CDSCO) announced the offer of rewards for whistleblowers who report on goods that are confirmed as “spurious, adulterated, and/or misbranded.” Rewards have been set at up to 20% of the total value of intercepted shipments of goods. The maximum value of the reward is 2.5m […]

Changes in India’s Serialization Expectations

India announced in a late June public notice that it now considers mono cartons containing strips, vials, or bottles of pharmaceutical products as secondary, rather than primary packaging, for the purposes of serialization. The Directorate General of Foreign Trade of India requires secondary packaging to carry a barcode encoding a unique product identification code, batch […]

EMA Concept Paper on Validating QC Methods

EMA introduced a concept paper in late June for the creation of a guidance on how a method for quality control may be validated for use in a lab or product development arena.

Success of Eight-Year Amgen Effort to Improve Deviation Investigations and Follow-up Actions Writ Large on Quality Metrics and Bottom Line

The results of an eight-year program at Amgen to improve its deviation investigations and follow-up actions demonstrate how concentrating on finding and addressing root causes can have a substantial impact on a firm’s quality assurance and bottom-line....

EU Launches Genuine Online Pharmacy Logo Scheme

In late June, EC introduced a logo that will allow patients to identify authorized online pharmacies providing authentic medicines.

FDA and Customs Announce “Trusted Trader Program”

In mid-June, FDA and the US Customs and Border Protection (CBP) announced the launch of a new “Trusted Trader” program meant to expedite the import of products made by companies that are known to meet a quality selection standard. Participants in the program will be given incentives such as exemption from “non-intrusive” inspections. To qualify, participants […]
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