Product Registration

Product Registration

We are committed to registering our products in a timely fashion in markets where they are needed in order to better address public health needs.

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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 and 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 (WHO) to prequalify our products, where appropriate, to expedite access in low-income countries (LICs)

An important goal for our company is to reduce the historic gap in product introduction between developed and developing countries.

One way in which we strive to reach this goal is by prequalifying medicines and vaccines through the WHO. The WHO prequalification facilitates procurement by UN agencies, which often procure health care products in developing countries in the absence of reliable national medicines authorities that could certify those products as meeting required quality, safety and efficacy standards. The WHO prequalification program covers medicines for HIV, TB, malaria, neglected tropical diseases, influenza, reproductive health and diarrhea, in addition to vaccines. This prequalification is an important step toward fostering global access.

We have also focused on addressing developing-country needs by adding features and product improvements to respond to the WHO criteria for vaccines that are candidates for programmatic suitability for prequalification. These features include vaccine vial monitors (VVMs), the acceptability of a two-dose regimen for HPV vaccines, and use in controlled-temperature-chain conditions.

As of March 31, 2018, we have secured WHO pre qualification for the following products:

ProductInternational Nonproprietary Name (IN)  Date of Prequalification
Family Planning
MARVELON 28®Ethinylestradiol + Desogestrel  October 2010
EXLUTON®Lynestrenol  June 2010
IMPLANON NXT®Etonogestrel  May 2013
Vaccines
PedvaxHIB®Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) February 2003
MMR-II®Measles, Mumps, Rubella Virus Vaccine Live December 2008
ROTATEQ®Rotavirus Vaccine, Live, Oral, Pentavalent October 2008
GARDASIL® Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (including a VVM) May 2009
GARDASIL® Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (two-dose regimen to support its programmatic feasibility in developing countries) October 2014
GARDASIL®Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (compatibility for use in a controlled temperature chain to facilitate its administration in high-temperature, low-cold-chain infrastructure areas of developing countries) May 2016
GARDASIL®9Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (including a two-dose-regimen variation) February 2018
VARIVAX®Varicella Virus Vaccine Live (first varicella vaccine to receive WHO prequalification) February 2018
HIV/AIDS Treatments
STOCRIN®Efavirenz (600mg tablet, Oral Solution 30mg)
Efavirenz (50 mg tablet, 200mg tablet)
May 23, 2006
May 14, 2008
CRIXIVAN®Indinavir Sulfate May 23, 2006

REGISTRATION STATUS

In order to make our products available to the people who need them throughout the world, we registered 143 products and devices in 2017. 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 transparency regarding the registration status of the company’s products, we continue to disclose registration information for ROTATEQ, GARDASIL and our four antiretrovirals:

  • GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant]
  • ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent)
  • ATRIPLA® (efavirenz, emtricitabine, tenofovir disoproxil fumarate)
  • CRIXIVAN® (indinavir sulfate)
  • ISENTRESS® (raltegravir)1
  • STOCRIN® (efavirenz)

INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES IN THE DEVELOPING WORLD

While our company files for patents in commercially significant markets to provide the continued incentive to support innovation, given the challenges that many people in LICs face to afford certain medicines and the very substantial resource constraints facing their governments, we have had a long-standing general policy of not filing for patents for our products in LICs, and currently do not file in any LIC defined as such by the World Bank in its Country and Lending Groups classifications. Moreover, as evidenced by our announcement together with the Medicines Patent Pool of a licensing agreement for pediatric formulations of raltegravir (a key medicine approved for children under 12 years of age living with HIV) covering 92 low- and lower-middle-income countries, we are committed to expanding access to medicines globally, including through the availability of high-quality generics in developing countries.

Learn more about our commitment to register our:

Performance

Product Registration2013 2014 2015 2016 2017
New product and device registrations1, 2, 3179 176 156 143 143
Local regulatory agency GCP/PV training requests fulfilled that will help strengthen agency capabilities with their GCP/PV compliance oversight role4 Online
Products submitted that have achieved WHO prequalification (cumulative) 11 11 11 11 13
1. Data include new products and new indications.
2. For information on new registrations by region, visit our Clinical Research section.
3. Data for all years have been updated based on a tracking system upgrade that corrected miscounts in prior years.
4. For information on local regulatory agency GCP/PV training requests, visit our Clinical Research section.