Athletes wishing to compete in female events at September's World Championships in Tokyo will need to take a test to determine their biological sex.
World Athletics announced on Wednesday that it had approved the introduction of testing to avoid what its president Sebastian Coe called a "biological glass ceiling".
From September 1, athletes will need to undergo a cheek swab or blood test - only once in their lifetime - to determine if they are biologically female and therefore eligible for the female category in world-ranking events.
The World Championships get under way on September 13.
World Athletics said the testing protocol would be overseen by national federations. The move to introduce testing followed the World Athletics Council's approval in March of recommendations from its Gender Diverse Athlete Working Group.
Coe said: "The philosophy that we hold dear in World Athletics is the protection and the promotion of the integrity of women's sport.
"It is really important in a sport that is permanently trying to attract more women that they enter a sport believing there is no biological glass ceiling.
"The test to confirm biological sex is a very important step in ensuring this is the case.
"We are saying, at elite level, for you to compete in the female category, you have to be biologically female. It was always very clear to me and the World Athletics Council that gender cannot trump biology.
"We particularly want to thank our member federations for their support and commitment in the implementation of these new regulations."
Earlier this month, the Grand Chamber of the European Court of Human Rights ruled that two-time Olympic 800 metres champion Caster Semenya's right to a fair hearing in the Swiss legal system had been violated.
Semenya, an athlete with differences of sexual development (DSD), has fought a long legal battle since World Athletics introduced rules requiring her to lower her testosterone levels in order to compete.
The ECHR ruling is almost certain to mean the case returns to the Swiss courts but at this stage has no impact on track and field's eligibility criteria.
World Boxing, now recognised by the International Olympic Committee as that sport's official international federation, has also introduced mandatory sex testing in order to be eligible for its female events.
IOC president Kirsty Coventry said last month there was "overwhelming support" within her organisation to ensure fairness in female sport, and said a working group had been set up to find "consensus" on the issue.
PA
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