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Christian Alejandro Lopez-Silva

Dr. Christian Alejandro Lopez-Silva

Partner
Baker & McKenzie Abogados, S.C.

Biography

Dr. Lopez Silva is the head of Healthcare & Life Sciences Industry Group in Mexico, as well as a member of the Steering Committee of the North American and Latin America Healthcare Group. He has more than 17 years of experience in regulation of life sciences, pharmaceutical law and biotechnology matters, having worked in the private and public sectors and at the national and international level. For several consecutive years, Dr. Lopez Silva has led the rankings for Life Sciences both nationally (Chambers Latin America) and internationally (Chambers Global).

Practice Focus

Dr. Lopez Silva regularly advises on regulatory, transactional and intellectual property matters for the manufacturing, import, distribution, advertising, labeling, commercialization and post-market vigilance of medicines, medical devices, food and beverages, cosmetics, seeds, veterinary products, chemicals, alcohol and tobacco.

He has experience in government relationship, administrative proceedings, registration of products, as well as consultancy and contractual work

Representative Legal Matters

  • Designing and executing a strategy for a German pharmaceutical company in relation to the pre-submission regulatory meeting with the New Molecules Committee.
  • Advising an Italian chocolate company on issues relating to the use and labelling of food additives, including a government relationship strategy to obtain ruling requests from the Sanitary Authority.
  • Advising a US pharmaceutical company to implement the linkage system between patents and health authorizations in Mexico.
  • Advising a US herbal products company to register products in Mexico, including dietary supplements, herbal remedies and herbal drugs.
  • Advising a US pharmaceutical company on several contractual and regulatory issues relating to clinical trials.
  • Advising an Argentinian contract research organization on regulatory approvals for research protocols and import/export permits.
  • Advising a French medical devices company on the rules for promoting and advertising products during different stages in their life cycle.
  • Advising a US medical devices company in a global transaction to sell a division on specialized medical equipment.
  • Advising several pharmaceutical companies on the new regulatory framework for biotechnological drugs and biosimilars in Mexico.
  • Advising several pharmaceutical companies on how to navigate the changing regulation of orphan drugs in Mexico.

Professional Associations and Memberships

  • Health and Life Sciences Committee for the IBA (International Bar Association) based in London - Member
  • Mexican Association for Health Law and Regulation (AMDERSA) - Founding President
  • British Chamber of Commerce in Mexico - Life Sciences & Healthcare Business Group - Member
  • International Law Association - Committee on International Law on Biotechnology based in London - Member
  • National Association of Corporate Lawyers (ANADE) - Committee on Health Regulation - Coordinator

Admissions

  • Mexico (2001)

Education

  • University of Sheffield (Ph.D. Life Sciences International Regulation) (2008)
  • University of Sheffield (Master's Degree Biotechnological Law and Ethics) (2003)
  • Instituto Tecnológico Autónomo de México (J.D. Honors)

Languages

  • English
  • Spanish

Publications

Author, “International trade law and local health law: regulatory harmonisation and regulatory convergence,” IBA Committee on Healthcare & Life Sciences Newsletter, Vol 3 (1), September 2018

Author, "Increased attention of antitrust authorities on the healthcare industries in Mexico," IBA Committee on Healthcare & Life Sciences Newsletter, Vol 2 (1), September 2017.

Author, "A legal model for predictive medicine," Chapter X, Medicine Models and Law Models, Coordinators, Jose Ramon Cossio and Ruy Perez Tamayo, Ed. Tirant Lo Blanch, Mexico, 2015

Author, "Mexico Recovers Leadership on Regulation of Biosimilar Drugs," Gaceta Medica de Mexico, Vol. 148 (1), January 2012

Author, "Regulation of Life Sciences in Mexico," La Barra, Revista de la Barra Mexicana Colegio de Abogados, No. 84 (3), October 2012