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Focus on Regulation

Tag Archives: India

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

Earlier today, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of [pharmaceutical] manufacturing facilities that meet FDA requirements,” and that the Agency will begin relying “on the inspectional data obtained by these eight regulatory agencies” immediately. 

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to Continue Shifting Inspections and Enforcement Focus to Asia

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug Administration (FDA) and the European Union (EU) today announced that they have enhanced their agreement on mutual recognition

India’s New BIT and Arbitration Law Send Mixed Signals to Foreign Investors

On December 28, 2015, the Government of India released the text for its revised model Bilateral Investment Treaty (BIT). In this release, the Government of India also announced that the Department of Economic Affairs will be leading all negotiations on BITs and investment chapters of trade agreements to ensure continuity between trade and investment issues.

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

Cooperation between the EU and India on antitrust matters

On 21 November 2013, the European Commission signed a Memorandum of Understanding (“MoU“) with the Competition Commission of India. A copy has just been published on the European Commission’s website. The aim of the MoU is to further strengthen cooperation between the two parties in the area of antitrust enforcement.

Hogan Lovells Hosts Roundtable on India Women and Water

Hogan Lovells recently hosted a roundtable discussion entitled, “Water and Women: Village Development in Rural India”, which brought together non-governmental organizations, federal agencies, and corporations to exchange ideas and experiences in improving access to water in rural India. The roundtable was initiated by the Institute of Rural Research and Development (IRRAD) and the Seghal Family

USTR and State Complete Three-Year Review and Unveil 2012 Model BIT

The State Department and the US Trade Representative (USTR) unveiled last week the new US Model Bilateral Investment Treaty (BIT). The release of the 2012 Model BIT signifies the completion of an Obama Administration campaign promise to conduct a thorough review of U.S. investment policy. The 2012 Model BIT retains the core protections set forth