Access to Health

Access to Health

Product Registration

Product Registration
Access to Health
Main

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.

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 to prequalify our products, where appropriate, to expedite access in low-income countries

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 World Health Organization (WHO). 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 WHO criteria for vaccines that are candidates for programmatic suitability for prequalification (PSPQ). 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 June 2016, we have secured WHO prequalification for the following products:

Family Planning Products

  • EXLUTON® (lynestrenol oral contraceptive)
  • IMPLANON® (etonogestrel implant)
  • MARVELON 28® (desogestrel – ethinyl estradiol)
  • IMPLANON NXT® (etonogestrel implant)

Vaccines

  • GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant]─including a vaccine vial monitor (VVM)
  • Two-dose regimen for GARDASIL to support its programmatic feasibility in developing countries
  • GARDASIL compatibility for use in a controlled temperature chain to facilitate its administration in high-temperature, low-cold-chain infrastructure areas of developing countries
  • ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent)
  • MMR-II® (Measles, Mumps, Rubella Virus Vaccine Live)
  • PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)]

By the end of 2016 we expect to receive WHO prequalification for:

  • GARDASIL9®, equipped with a VVM and including a 2-dose-regimen variation
  • VARIVAX®, making it the first varicella vaccine to receive WHO prequalification and to be used in Middle-Eastern countries

And in 2017, we intend to seek WHO prequalification for GARDASIL9 in a controlled-temperature-chain setting.

In addition, our investigational Ebola Zaire vaccine, V920 (rVSV∆G-ZEBOV-GP, live attenuated), has been accepted by the WHO for review for Emergency Use Assessment and Listing (EUAL). The EUAL procedure is designed to expedite the availability of vaccines needed for public health emergencies such as another outbreak of Ebola.

HIV/AIDS Treatments

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

In addition, we have submitted ISENTRESS® (raltegravir) for WHO prequalification; the product dossier is currently under review. All of our formulations of ISENTRESS, including the 400mg tablet, the 100mg and 25mg chewable tablets, and the granules for suspension, have been approved by the U.S. Food and Drug Association (FDA) and the European Medical Agency, making these formulations eligible for purchase by both the U.S. Presidents Emergency Plan for AIDS Relief (PEPFAR) program and the Global Fund for AIDS, TB, and Malaria.

In order to make our products available to the people who need them throughout the world, we registered 156 products and devices in 2015. 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.

Registration Status

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 (ARVs):

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 inability of most of the population in the low-income countries (LICs) to afford 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 recent 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:

View our public policy statement, “Intellectual Property and Access to Medicines in the Developing World.”

Performance
Registration20112012201320142015
New product and device registrations1,2,3179204179176156
Local regulatory agency GCP/PV training requests fulfilled that will help strengthen agencies’ capabilities with their GCP/PV compliance oversight role4OnlineOnlineOnlineOnlineOnline
Products submitted that have achieved WHO prequalification (cumulative)1010111111
1Data include new products and new indications.
2For information on new registrations by region, visit our Clinical Research section.
3Data for all years have been updated based on a tracking system upgrade that corrected miscounts in prior years.
4For information on local regulatory agency GCP/PV training requests, visit our Clinical Research section.