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We are committed to registering our products in a timely fashion in markets where they are needed.

Our Commitments

  • We will work to initiate registration of our products in all countries where there is a public health need in a timely manner in conjunction with local regulatory authorities
  • We will work to strengthen the regulatory science capabilities of local regulatory authorities to expedite product registrations
  • We will work with the World Health Organization to prequalify our products, where appropriate, to expedite access in low-income countries

In addition, an important goal is to reduce the historic gap in product introduction between developed and developing countries. One way we strive to reach this goal is by prequalifying medicines and vaccines through the World Health Organization (WHO). WHO prequalification is required by UN agencies, which often procure healthcare products throughout developing countries in the absence of reliable national medicines authorities that would certify products for meeting required quality, safety and efficacy standards. As such, WHO prequalification is an important step toward fostering global access.

We have secured WHO prequalification for the following products:

Family Planning Products

  • EXLUTON® (lynestrenol oral contraceptive)
  • IMPLANON® (etonogestrel implant)
  • MARVELON® (desogestrel – ethinyl estradiol)

Vaccines

  • GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant]
  • ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent)
  • MMR-II® (Measles, Mumps, Rubella Virus Vaccine Live)
  • Pedvax HIB (Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate))

HIV/AIDS Treatments

  • STOCRIN® (efavirenz)
  • CRIXIVAN® (indinavir sulfate)
  • ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)

In 2013 we anticipate receiving prequalification of IMPLANON NXT® (etonogestrel) and plan to submit applications to the WHO for adult and pediatric formulations of ISENTRESS® (raltegravir).

In order to make our products available to the people who need them throughout the world, we registered 437 products and devices in 2012. The majority of these products were registered in low- and middle-income countries in the Asia-Pacific, Central and Eastern Europe, Middle East and Africa, and Americas regions.

To increase the transparency of the company’s product registration status, we are disclosing registration information for ROTATEQ, GARDASIL and our four antiretrovirals (ARVs), and updating this information every six months. Click below for details:

Registration 2011 2012
New product and device registrations1,2 334 437
Local regulatory agency GCP/PV training requests fulfilled that will help strengthen agency capabilities with their GCP/PV compliance oversight role3 Online Online
Products submitted that have achieved WHO prequalifications 10 10
11 Data includes new products and new indications.
2 For information on new registrations by region, visit our Clinical Research section.
3 For information on local regulatory agency GCP/PV training requests, visit our Clinical Research section.

 

Learn more about our commitment to register our:

Last Updated January 14, 2014