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Focus on Regulation

MHRA Published New GMP Data Integrity Guidance

The UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has published new guidance on data integrity in the context of good manufacturing practices (GMP).

Data integrity forms a key part of pharmaceutical quality systems. According to the MHRA guidance, the purpose of data integrity is to ensure that the accuracy, completeness, content, and meaning of data is retained throughout the data lifecycle. The MHRA already requires pharmaceutical manufacturers and analytical laboratories to review their governance systems to ensure data integrity as part of their GMP self-inspection program, in line with EU GMP legislation and standards, such as the GMP Directive and the European Commission Guidance in EudraLex Volume 4.

The new guidance, which applies to data in both hardcopy and electronic format, provides further clarity as to the MHRA’s expectations, including:

  • in addition to policies and staff training on data integrity, consideration should be given to organizational (i.e. procedures) and technical (e.g. computer system access) controls within a data governance system; and
  • the design and operation of data governance systems should be proportionate with the risk to product quality and manufacturers should document the supporting rationale for the level of effort and resource they assigned to their system.

The guidance also sets out definitions and guidance for a number of terms, including “data”, “raw data”, “metadata”, “data governance”, “data integrity”, “data retention” and “audit trail”.

The publication of this guidance indicates the increasing importance that the MHRA is placing on data integrity in ensuring the quality of medicines. For further information visit https://www.gov.uk/government/publications/good-manufacturing-practice-data-integrity-definitions.

U.S. FCC Decision Triggers Potential Sea Change in Broadband ISP Data Privacy and Security Requirements

FCC logoIn its recent Open Internet Order (“Order”), the U.S. Federal Communications Commission (“FCC”) determined that broadband Internet access services are appropriately classified as common carrier “telecommunications services” under the Telecommunications Act of 1996.  In doing so, the agency established itself as the primary U.S. data privacy and security regulator for those services and triggered additional requirements under the Act.  It also promised a future rulemaking that could result in a sea change in how ISPs and their business partners interact with consumer data.  Although the decision is widely expected to be appealed in court, organizations operating across the broadband ecosystem would be prudent to assess the potential impact on their current and planned online service portfolio.

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Who’s Who Legal Names Hogan Lovells as Top Global Life Sciences Practice

Who’s Who Legal has named the Hogan Lovells Global Life Sciences Practice to the “top spot” among law firms worldwide for 2015, citing “an unprecedented level of recognition.” In recognizing the Hogan Lovells Life Sciences Practice as both global and comprehensive, the publication identified 35 Hogan Lovells lawyers who stand out, an unprecedented number from any one firm. Click here for the article.

Since 1996, Who’s Who Legal has focused on identifying “the foremost legal practitioners in multiple areas of business law.”

Outlook for 2015: Antitrust Litigation in the Pharma Industry – More Than Just Actavis Progeny

In 2014 there were a number of significant antitrust developments for the pharmaceutical industry. These involved not only challenges with respect to pharmaceutical patent litigation settlements (so-called “reverse payment” agreements), but also investigations and challenges to conduct related to product reformulations, Risk Evaluation and Mitigation Strategies (REMS), and FDA citizen petitioning activity.

Read More: Outlook for 2015: Antitrust Litigation in the Pharma Industry – More Than Just Actavis Progeny

Update on Sanctions Related to Venezuela

On 8 March 2015, President Obama signed Executive Order 13692 (the Order) imposing targeted sanctions against persons in Venezuela.

Read More: Update on Sanctions Related to Venezuela

Office for Civil Rights Issues New Case Processing Manual

Department of EducationAt the end of February 2015, the U.S. Department of Education’s Office for Civil Rights (OCR) issued a new Case Processing Manual, which updates (and supersedes) its 2010 manual. As described in the manual’s introduction, it provides “the procedures to promptly and effectively investigate and resolve complaints, compliance reviews and directed investigations to ensure compliance with the civil rights laws enforced by OCR.”

Among other revisions, the new manual:

  • states that while statistical data alone are not sufficient to warrant opening an investigation, such data “can serve to support the opening of an investigation when presented in conjunction with other facts and circumstances” (Section 101); and
  • includes a description of OCR’s Rapid Resolution Process, an expedited case processing approach (Section 207).

CFIUS Annual Report — Review Process Appears Increasingly Stringent

The recently published annual report to Congress by the Committee on Foreign Investment in the United States (CFIUS), a U.S. government interagency committee that conducts national security reviews of transactions that could result in control of a U.S. business by a foreign person, suggests that the committee’s reviews are becoming increasingly stringent.

Read More: CFIUS Annual Report — Review Process Appears Increasingly Stringent 

President Obama’s Visit to India Raises Hopes for More Significant Nuclear Cooperation With India but Leaves Lingering Uncertainty for Suppliers

President Barack Obama’s January 2015 visit to India began with the announcement of an agreement with Prime Minister Narendra Modi to facilitate cooperation between the two countries on civilian nuclear technology.

Read More: Obama’s Visit to India Raises Hopes for More Significant Nuclear Cooperation With India but Leaves Lingering Uncertainty for Suppliers

NTIA Launches Multistakeholder Process to Develop Privacy Best Practices for Commercial and Private Unmanned Aircraft Systems

On March 4, the U.S. Commerce Department’s National Telecommunications and Information Administration announced it is seeking comments on how to structure a new multistakeholder process to develop best practices for commercial and private unmanned aircraft systems use.

Read More: NTIA Launches Multistakeholder Process to Develop Privacy Best Practices for Commercial and Private Unmanned Aircraft Systems

USCIS Extends Eligibility for Employment Authorization to Certain H-4 Dependent Spouses of H-1B Nonimmigrants

On 25 February 2015, the Department of Homeland Security (DHS) U.S. Citizenship and Immigration Services (USCIS) published its final rule, effective 26 May 2015, extending eligibility for employment authorization to certain H-4 dependent spouses of H-1B nonimmigrants seeking employment-based lawful permanent resident (LPR) status, who meet certain conditions related to that LPR process. This is a significant change, as H-4 spouses previously were not eligible to work in the United States at all. The change in the regulations seeks to attract and retain highly skilled foreign workers by alleviating personal and economic strains during the transition to LPR status. However, please note that this employment authorization does not extend to all H-4 spouses.

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