Latest news with #regulations
Yahoo
12 hours ago
- Business
- Yahoo
Pharma packaging meets tough regulations
In the highly regulated pharmaceutical industry, packaging plays a crucial role in ensuring the safety, efficacy, and compliance of medications. It is not just about containing the drug; it serves as a barrier between the product and external factors, such as contaminants, moisture, light, and air. But packaging in the pharmaceutical sector is far more than a protective covering—it must adhere to a stringent set of regulations that vary across countries. These regulations are designed to protect consumers, maintain product integrity, and prevent fraud. As the pharmaceutical sector grows, so too do the complexities surrounding its packaging requirements. Understanding the importance of pharma packaging is vital for manufacturers, suppliers, and consumers alike. For decades, packaging design, materials, and labelling have had to evolve to keep pace with increasing regulatory demands, new drug innovations, and changing consumer expectations. In this article, we'll explore the key regulations governing pharmaceutical packaging and examine how manufacturers are adapting to meet these tough standards. Pharmaceutical packaging is one of the most regulated areas in the entire manufacturing industry. The regulations that govern packaging are designed to ensure that products are safe for use and remain unaltered until they reach the consumer. These regulations focus on various aspects of packaging, including materials, labelling, and traceability. Most importantly, they protect against the risk of counterfeit drugs, a growing concern globally. In the European Union (EU), the regulations for pharmaceutical packaging are primarily governed by the EU's Good Manufacturing Practice (GMP) guidelines. These guidelines cover the entire lifecycle of a drug, from manufacturing to packaging, and require manufacturers to use packaging that maintains the drug's stability, safety, and efficacy. One of the most stringent regulations involves child-resistant packaging. This is required for products that could pose a poisoning risk, such as medicines containing high doses of analgesics, paracetamol, or opioids. In the United States, the Food and Drug Administration (FDA) plays a central role in overseeing pharmaceutical packaging regulations. The FDA enforces regulations concerning the packaging materials used in pharmaceuticals, ensuring that packaging does not interfere with the drug's quality. Similarly, the FDA's Drug Approval Process includes extensive testing for packaging to ensure that it meets requirements for tamper-evidence, labelling accuracy, and stability. Countries outside the EU and the US also have their own regulatory frameworks. Japan, for example, mandates that drug packaging must feature detailed instructions and warnings in both Japanese and English. Packaging regulations in China focus on the durability of materials, while India's packaging requirements include anti-counterfeit measures like holographic seals and track-and-trace systems. Navigating the complexity of these varying standards presents a challenge for global pharmaceutical companies. With the rise in global drug counterfeiting, pharmaceutical packaging has evolved to include several security features designed to protect consumers and ensure product authenticity. Packaging plays an instrumental role in preventing tampering, ensuring that medications reach consumers in their original, unaltered state. Tamper-evident features are a critical component of pharmaceutical packaging. These features make it apparent if a product has been opened or altered in any way. Common tamper-evident mechanisms include seals, shrink bands, breakable caps, and special adhesive labels. For instance, a bottle with a tamper-evident seal will show visible signs of damage if someone tries to open it. These features are essential to preventing fraud, which can lead to serious public health risks, including the distribution of counterfeit or substandard drugs. Beyond tamper evidence, the growing concern over counterfeiting has led to the incorporation of high-tech security features such as holograms, QR codes, and RFID (Radio Frequency Identification) tags. These innovations not only serve as a deterrent to counterfeiters but also allow for the traceability of medications from manufacturing to the point of sale. The track-and-trace system, mandated in some regions, enables regulators and pharmaceutical companies to trace a drug's path along the supply chain, ensuring that the product is authentic and has been stored and handled appropriately. As the pharmaceutical industry continues to face growing pressure to reduce its environmental impact, packaging is one area where significant improvements are being made. Pharmaceutical companies are increasingly exploring ways to reduce waste, lower carbon footprints, and use more sustainable materials while maintaining compliance with regulatory requirements. One of the primary concerns regarding the environmental impact of pharmaceutical packaging is the excessive use of plastic. Packaging waste, particularly from single-use plastic bottles and blister packs, contributes to environmental pollution. In response, many companies are now adopting eco-friendly alternatives, such as recyclable or biodegradable packaging materials. Some companies have even moved towards using plant-based plastics, which reduce reliance on fossil fuels and contribute less to pollution. In addition to choosing sustainable materials, manufacturers are focusing on improving packaging designs to minimise waste. For instance, reducing the size of packaging or opting for more compact designs helps to lower material consumption and the energy needed for production and transport. The growing use of minimalist packaging also aligns with broader sustainability trends and consumer demand for greener products. Regulations governing the environmental impact of packaging are already in place in many regions. The EU, for example, has introduced the Waste Framework Directive, which aims to reduce packaging waste and encourage the use of recycled materials. The directive is part of a broader effort to transition towards a circular economy, where resources are reused and recycled rather than disposed of. Pharmaceutical companies must navigate these regulations while ensuring that their packaging continues to meet safety and compliance standards. Pharmaceutical packaging is a critical part of ensuring the safety, effectiveness, and compliance of medications. From tamper-evident features to sustainable packaging solutions, pharmaceutical companies must adhere to an array of regulations that vary by region and product. These regulations are designed not only to protect consumers but also to ensure that drugs maintain their integrity from the manufacturer to the patient. As the global demand for medicines continues to grow, the pharmaceutical industry will face new challenges in packaging. However, with innovations in materials, security features, and sustainability, the industry is likely to evolve in ways that continue to prioritise both consumer safety and environmental responsibility. With regulatory bodies remaining vigilant and the rise of technology offering new solutions, pharmaceutical packaging will undoubtedly continue to meet tough regulations for years to come. "Pharma packaging meets tough regulations" was originally created and published by Packaging Gateway, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
18 hours ago
- Business
- Yahoo
Will Dunleavy's freeze on new regulations affect paid sick leave for Alaskans?
The Alaska and American flags fly in front of the Alaska State Capitol on Tuesday, April 22, 2025. (Photo by James Brooks/Alaska Beacon) Two weeks ago, Alaska Gov. Mike Dunleavy announced a hiring freeze for most state agencies, paused new state regulations, and restricted state workers' travel. The governor's administrative order arrived amid growing concerns about state spending, and much of it is similar to orders issued during the COVID-19 pandemic emergency and the oil price shock of the mid-2010s. But this order has a new wrinkle: a pause on new state regulations. 'In order for agencies to focus their attention on the State's core mission of providing essential services to Alaskans and maximizing operational efficiency, there is, effective immediately, a freeze on the promulgation of new regulations by all agencies. This freeze does not apply to regulations currently out for public notice,' the governor's new order states. If laws enacted by the Legislature and governor are the building blocks of state government, regulations are the mortar that holds them together: Regulations, proposed by state agencies or boards and commissions, cover the details that laws don't, prescribing how state agencies should implement those laws. 'Governor Dunleavy issued Administrative Order 358 to ensure we are spending wisely and living within our means. This temporary pause on new regulations gives agencies time to evaluate priorities and reduce unnecessary regulatory growth,' said Jessica Bowers, a spokesperson for Dunleavy. Since Dunleavy's order, the state's public records system shows only one new regulations package has been posted for public comment. In the same period last year, the online public records system shows seven. There were three during the same stretch of 2023 and five during that stretch of 2022. This year, one of the biggest items affected by the governor's order is a packet of regulations that would fully implement last year's Ballot Measure 1, which requires paid sick leave and a minimum wage increase for workers starting July 1. The measure, which was approved by 58% of participating Alaska voters last year, also forbids 'captive audience meetings,' in which employees must listen to an employer's views on religion, politics or unions. New regulations require a 30-day comment period where the public can suggest changes to the final draft, and those regulations typically don't become effective until 30 days after the final version is signed by the lieutenant governor. In March, Adam Weinert, a special assistant to state Department of Labor Commissioner Cathy Muñoz, said that 'the regulation packet is currently with the Alaska Department of Law, and we intend to have the packet out for a 30-day public comment in the near future.' More than two months later, the packet still has not been published for public comment. The Department of Labor has not answered multiple requests for further information. The delay has alarmed some of the measure's supporters, who think it could be part of a national pattern. In Nebraska and Missouri, voters also passed paid sick leave ballot measures last year. In both places, state legislators proceeded to overturn those ballot measures this spring. Here in Alaska, five Republican members of the state House introduced a bill that would roll back Alaska's voter-approved law. 'As those issues have won at the ballot box, really since 2016, we have seen an escalation of attacks to direct democracy and voter-approved initiatives,' said Chris Melody Fields, executive director of the Ballot Initiative Strategy Center, a national progressive organization. 'We've seen that especially on the economic justice ballot measures that were passed in 2024,' she said. The Alaska bill lacks the support needed to pass the House or Senate and may be unconstitutional, which leaves regulatory hurdles as the last obstacle before it becomes effective. Bowers, in the governor's office, cited the text of the governor's administrative order and said that agencies 'can submit a waiver to move forward with paused regulations if the regulations are necessary to protect the safety of the public or to meet other essential State responsibilities.' By email, she confirmed that the Department of Labor has submitted a waiver request and that it is under review. The Alaska Department of Law, which has been examining the regulations package for more than two months, did not answer a question on Friday seeking information about the status of that review. Joelle Hall, president of the Alaska chapter of the AFL-CIO, a federation of 63 national and international labor unions, said that regardless of what happens with the regulations, Ballot Measure 1 will become law on July 1. She supported the measure and has been tracking its implementation with interest. 'Those regs need to have a 30-day comment period … they should have been out 90 days ago, so they could have taken in public comment,' she said. Without regulations, Alaskans will still be entitled to sick leave and a higher minimum wage, but employers might not know how to keep track of that sick leave and report it properly, she said. She noted that the Department of Labor has an FAQ about the measure. Other organizations, including the Foraker Group and the law firm Landye Bennett Blumstein have also published detailed explanations on the new law going into effect. Attorney Scott Kendall said that a regulations package could still go forward after the law becomes effective. But Hall said that still leaves employers guessing. 'You're going to have a lot of employers who are confused about how they're going to track things,' she said. Of the state's decision to wait on releasing regulations, she said, 'I'm not sure what they think they're doing aside from confusing people.'
RNZ News
21 hours ago
- Business
- RNZ News
Councils plead for bipartisan Resource Management Act reform
RMA Reform Minister Chris Bishop and Transport Minister Simeon Brown announce extensions for ports' permits at a press conference in Auckland's Parnell. Photo: RNZ/Marika Khabazi Regional councils want greater certainty and bipartisanship on regulations, as they gear up for an expected spate of rule changes when legislation replaces the Resource Management Act (RMA) next year . The government has announced sweeping changes to the rules governing councils' oversight of everything - from housing, to mining, to agriculture - under the RMA, and these have been released for public feedback. Speaking on behalf of Te Uru Kahika - Regional and Unitary Councils of Aotearoa, Greater Wellington chair Daran Ponter said when policy resets every three years, regulators scramble to deliver the new government's national direction. "As regional councils we have effectively seen these national instruments landing on our lap as regularly as every three years. The music just has to stop. "We need certainty, we need to be able to have the chance as regulators to actually bed in policies and rules and provide a greater certainty to people who want to do things - who want to build, who want to farm, who want to mine - because the bigger block on those things at the moment, at national and regional levels, is that we continue to change the rules." Ponter said bipartisanship on regulations was needed to provide certainty. "I don't want to be in the position in three or six years' time that all the rules are going to change again, because the pendulum has swung the other way." Daran Ponter. Photo: RNZ / Dom Thomas Ponter said in recent years there had been "more radical swings" in policy under successive governments. "At the moment, the meat in the sandwich of all this, is the regional councils, who get accused of not doing this, or being woke, of being overly sympathetic to the environment... when all we are doing is following the national guidance that is put in front of us." The government has released three discussion documents covering 12 national policy statements and and national environmental standards, with the aim of having 16 new or updated ones by the end of 2025, ahead of legislation replacing the RMA next year. The consultation covers three main topics: infrastructure and development, the primary sector and freshwater. It is open from 29 May to 27 July. Doug Leeder, chair of Bay of Plenty Regional Council, has governed through the implementation of four National Policy Statements for Freshwater Management. He said implementing national direction was a major undertaking that involved work with communities, industry and mana whenua. "Councils contend with the challenge also faced by iwi and hapū, industry, and communities that the National Policy Statement for Freshwater Management has changed every three years since it has been introduced. "When policy resets every three years, it imposes significant costs on councils and communities, creates uncertainty for farmers and businesses, and makes it harder to achieve the long-term outcomes we all want. "We need to work towards something more enduring." Could bipartisanship on regulations work? "That's the challenge for the minister but also for the leaders of those opposition parties, as well," Ponter said. "Everybody is going to have to find a degree of compromise if something like that is going to work." But he said regional councils had worked constructively with successive governments and they were ready to do so again. Sign up for Ngā Pitopito Kōrero, a daily newsletter curated by our editors and delivered straight to your inbox every weekday.
Wall Street Journal
a day ago
- Business
- Wall Street Journal
Jamie Dimon: We Need to Fix U.S.
By Joseph Pisani Jamie Dimon, chief executive of JPMorgan Chase, said politicians should be focused on fixing the United States. 'We're not a team anymore,' he said at a conference Friday. He says there needs to be changes to regulations, tax law, inner-city schools and the military.
Bloomberg
a day ago
- Business
- Bloomberg
US Plans Wider China Tech Sanctions With Subsidiary Crackdown
The Trump administration plans to broaden restrictions on China's tech sector with new regulations to capture subsidiaries of companies under US curbs. Officials are drafting a rule that would impose US government licensing requirements on transactions with companies that are majority-owned by already-sanctioned firms, according to people familiar with the matter.
