A group of drug reg­u­la­tors from Aus­tralia, Cana­da, Sin­ga­pore, Switzer­land and the UK on Tues­day un­veiled their strate­gic plans for the next three years, lay­ing out how they’ll work to­geth­er on re­view­ing new drugs to re­duce du­pli­ca­tion across bor­ders.

While un­der­stand­ing that the bio­phar­ma in­dus­try is tru­ly glob­al, the group, known col­lec­tive­ly as the Ac­cess Con­sor­tium, seeks to bet­ter align their re­spec­tive reg­u­la­to­ry and pol­i­cy ap­proach­es for phar­ma­ceu­ti­cals, with an aim to fa­cil­i­tate faster ac­cess to high qual­i­ty, safe and ef­fec­tive health prod­ucts.

Through 2024 the con­sor­tium will seek to in­crease the num­ber and va­ri­ety of new drug ap­pli­ca­tions that the reg­u­la­tors col­lec­tive­ly as­sess, in ad­di­tion to cap­tur­ing lessons learned from the pan­dem­ic to im­prove their work-shar­ing process­es.

In ad­di­tion, the reg­u­la­tors will al­so ex­plore col­lab­o­ra­tions with na­tion­al health tech­nol­o­gy as­sess­ment or­ga­ni­za­tions, which can in­form re­im­burse­ment de­ci­sions.

The con­sor­tium al­so said, ac­cord­ing to its new strate­gic plan, that it’s con­sid­er­ing col­lab­o­ra­tive work on clin­i­cal tri­al de­signs and pro­vid­ing spon­sors with mu­tu­al av­enues for ad­vice.

The group said it will gauge its suc­cess based on in­creas­es in prod­ucts made avail­able, re­duced ef­fort and du­pli­ca­tion for in­dus­try and reg­u­la­tors, in­creased col­lab­o­ra­tion on man­u­fac­tur­ing and clin­i­cal in­spec­tions, and by de­creas­ing the av­er­age time to mar­ket for prod­ucts as­sessed un­der the group.

The orig­i­nal con­sor­tium formed in 2007 with all of the reg­u­la­tors ex­cept for the UK’s MHRA, which joined last Oc­to­ber.

MHRA is al­so now part of an­oth­er over­lap­ping group of reg­u­la­tors in­clud­ing the US FDA, Brazil’s AN­VISA, the Eu­ro­pean Med­i­cines Agency, Japan’s Phar­ma­ceu­ti­cals and Med­ical De­vices Agency, and all of the mem­bers of the Ac­cess Con­sor­tium. The reg­u­la­tors work to­geth­er on con­cur­rent sub­mis­sions and re­views of can­cer drugs as part of what’s known as Pro­ject Or­bis.

In April 2020, Seagen’s tu­ca­tinib in com­bi­na­tion with trastuzum­ab and capecitabine was the first new mol­e­c­u­lar en­ti­ty ap­proved un­der the FDA-led group of reg­u­la­tors.

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

A drug manufacturing facility in Mexico is drawing the ire of the FDA after it ignored the US regulator’s inspection requests and phone calls.

According to the warning letter issued on June 13, Glicerinas Industriales refused a pre-announced inspection during a phone call with FDA prior to the inspection at the company’s facility in Zapopan, Mexico, a city next to Guadalajara, which was planned for May 16 to May 20.